Medical device manufacturer
Bio-Rad
Bio-Rad holds 319 FDA 510(k) clearances across 84 product codes. Median elapsed review time is 39 days. openFDA lists no recall records naming the company. FDA publishes it under 2 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 319
- Product codes
- 84
- Median review
- 39 days
- Recall records
- 0
How does FDA spell Bio-Rad?
FDA publishes this company under 2 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 |
|---|---|---|
| BIO-RAD | device/registrationlisting | normalised |
| Bio-Rad | 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 Bio-Rad file in?
84 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 61 | 35 days | |
| DIF | Drug Mixture Control Materials | 31 | 37 days | |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 21 | 19 days | |
| LCP | Assay, Glycosylated Hemoglobin | 15 | 77 days | |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 14 | 23 days | |
| JJS | Controls For Blood-Gases, (Assayed And Unassayed) | 9 | 15 days | |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 9 | 45 days | |
| LKJ | Antinuclear Antibody, Antigen, Control | 9 | 6 days | |
| GGN | Plasma, Coagulation Control | 7 | 37 days | |
| JJT | Enzyme Controls (Assayed And Unassayed) | 6 | 23 days | |
| JSO | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | 6 | 218 days | |
| CGN | Acid, Folic, Radioimmunoassay | 5 | 70 days | |
| HKX | Tonometer, Ac-Powered | 5 | 47 days | |
| JJW | Urinalysis Controls (Assayed And Unassayed) | 5 | 41 days | |
| CDX | Radioimmunoassay, Total Thyroxine | 4 | 21 days | |
| CGI | Radioimmunoassay, Estriol | 4 | 23 days | |
| JPD | Hemoglobin A2 Quantitation | 4 | 76 days | |
| CDD | Radioassay, Vitamin B12 | 3 | 19 days | |
| CDF | Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin | 3 | 46 days | |
| CEP | Radioimmunoassay, Luteinizing Hormone | 3 | 23 days | |
| DHR | System, Test, Rheumatoid Factor | 3 | 78 days | |
| DIE | Heavy Metals Control Materials | 3 | 56 days | |
| GKA | Abnormal Hemoglobin Quantitation | 3 | 111 days | |
| HPT | Perimeter, Automatic, Ac-Powered | 3 | 41 days | |
| JPK | Mixture, Hematology Quality Control | 3 | 22 days |
Showing the 25 they file in most, of 84.
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 Bio-Rad 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 Bio-Rad cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K171061 | MRSASelect II | JSO | 262 | |
| K122187 | VRESELECT CULTURE MEDIUM | JSO | 105 | |
| K103684 | VRESELECT CULTURE MEDIUM | JSO | 308 | |
| K093678 | PLATELIA ASPERGILLUS EIA MODEL 62793 | NOM | 412 | |
| K100589 | MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS | JSO | 241 | |
| K081362 | PLATELIA LYME IGM | LSR | 42 | |
| K081212 | MRSASELECT - EXTENDED INCUBATION | JSO | 45 | |
| K080012 | PLATELIA LYME IGG ASSAY | LSR | 126 | |
| K070361 | MRSASELECT | JSO | 218 | |
| K060641 | PLATELIA ASPERGILLUS EIA, MODEL 62793 | NOM | 84 |
Source: openFDA device/510k · retrieved
Where is Bio-Rad registered?
FDA lists 2 registered establishments 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 Bio-Rad 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.