Medical device manufacturer
Sa Scientific , Ltd.
Sa Scientific , Ltd. holds 201 FDA 510(k) clearances across 22 product codes. Median elapsed review time is 55 days. openFDA lists no recall records naming the company. FDA publishes it under 3 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 201
- Product codes
- 22
- Median review
- 55 days
- Recall records
- 0
How does FDA spell Sa Scientific , Ltd.?
FDA publishes this company under 3 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| SA SCIENTIFIC, LTD | device/registrationlisting | normalised |
| Sa Scientific , Ltd. | device/510k | normalised |
| Sa Scientific, Inc. | device/510k | normalised |
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Sa Scientific , Ltd. file in?
22 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| GRM | Antisera, All Groups, Salmonella Spp. | 64 | 48 days | |
| GNC | Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. | 49 | 80 days | |
| GNB | Antisera, All Types, Shigella Spp. | 38 | 28 days | |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 9 | 63 days | |
| GSO | Antigens (Febrile), Agglutination, Brucella Spp. | 7 | 70 days | |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 6 | 18 days | |
| GSM | Antisera, Fluorescent, Brucella Spp. | 4 | 74 days | |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 4 | 45 days | |
| PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | 4 | 51 days | |
| GTY | Antigens, All Groups, Streptococcus Spp. | 3 | 61 days | |
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | 2 | 52 days | |
| DHA | System, Test, Human Chorionic Gonadotropin | 1 | 42 days | |
| GHM | Test, Sickle Cell | 1 | 115 days | |
| GNX | Antigens, Cf (Including Cf Control), Influenza Virus A, B, C | 1 | 24 days | |
| GOD | Antigens, Cf (Including Cf Control), Adenovirus 1-33 | 1 | 174 days | |
| GQG | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | 1 | 155 days | |
| GRL | Antigens, All Groups, Salmonella Spp. | 1 | 97 days | |
| GSK | Antiserum, Francisella Tularensis | 1 | 74 days | |
| GSL | Antigens, Slide And Tube, Francisella Tularensis | 1 | 70 days | |
| GSN | Antiserum, Positive And Negative Febrile Antigen Control Serum | 1 | 71 days | |
| LIQ | Enzyme Linked Immunoabsorbent Assay, Rotavirus | 1 | 147 days | |
| MJH | Legionella, Spp., Elisa | 1 | 393 days |
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Sa Scientific , Ltd. had a recall?
openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Sa Scientific , Ltd. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K132352 | SAS FLUALERT A & B, SAS INFLUENZA A TEST | GNX | 24 | |
| K100227 | SAS FLUALERT A&B, SAS INFLUENZA A TEST | PSZ | 28 | |
| K080380 | SAS INFLUENZA A & B TEST | PSZ | 526 | |
| K061496 | SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST | MJH | 393 | |
| K041441 | SAS INFLUENZA A TEST | PSZ | 51 | |
| K041439 | SAS INFLUENZA B TEST | PSZ | 51 | |
| K030628 | SAS RSV CONTROL KIT | JJX | 18 | |
| K022845 | SAS RSV TEST | GQG | 155 | |
| K022683 | SAS BLOOD/SERUM/URINE/URINE HCG | JHI | 126 | |
| K023270 | SAS STREPALERT | GTY | 16 |
Source: openFDA device/510k · retrieved
Where is Sa Scientific , Ltd. registered?
FDA lists 1 registered establishment for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Sa Scientific , Ltd. files next
Get an email when this company clears a new device, or when anything is recalled in a product code you follow.
Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.