Medical device manufacturer
Oxoid U.S.A., Inc.
Oxoid U.S.A., Inc. holds 93 FDA 510(k) clearances across 29 product codes. Median elapsed review time is 33 days. openFDA lists no recall records naming the company.
Updated · ingest status · JSON
- 510(k) clearances
- 93
- Product codes
- 29
- Median review
- 33 days
- Recall records
- 0
How does FDA spell Oxoid U.S.A., Inc.?
FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.
Which product codes does Oxoid U.S.A., Inc. file in?
29 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| JSK | Supplement, Culture Media | 30 | 35 days | |
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 11 | 33 days | |
| JSJ | Culture Media, Selective And Non-Differential | 10 | 18 days | |
| JSI | Culture Media, Selective And Differential | 7 | 12 days | |
| JSG | Culture Media, Non-Selective And Non-Differential | 5 | 33 days | |
| GMQ | Antigens, Nontreponemal, All | 3 | 18 days | |
| GNA | Antisera, All Types, Escherichia Coli | 2 | 133 days | |
| GTN | Antisera, Fluorescent, All Types, Staphylococcus Spp. | 2 | 308 days | |
| KZJ | Device, Gas Generating | 2 | 23 days | |
| DHR | System, Test, Rheumatoid Factor | 1 | 14 days | |
| FRC | Indicator, Biological Sterilization Process | 1 | 71 days | |
| GSO | Antigens (Febrile), Agglutination, Brucella Spp. | 1 | 18 days | |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 1 | 91 days | |
| IBG | Trypsin | 1 | 33 days | |
| JSC | Culture Media, General Nutrient Broth | 1 | 18 days | |
| JSD | Culture Media, Selective Broth | 1 | 49 days | |
| JSF | Culture Media, Single Biochemical Test | 1 | 45 days | |
| JSO | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | 1 | 21 days | |
| JSP | Kit, Anaerobic Identification | 1 | 308 days | |
| JST | Kit, Fastidious Organisms | 1 | 18 days | |
| JSX | Kit, Identification, Neisseria Gonorrhoeae | 1 | 32 days | |
| JTL | Plasma, Coagulase, Human, Horse And Rabbit | 1 | 93 days | |
| JTM | Anaerobic Box Glove | 1 | 36 days | |
| JTN | Susceptibility Test Discs, Antimicrobial | 1 | 48 days | |
| JTZ | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | 1 | 33 days |
Showing the 25 they file in most, of 29.
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 Oxoid U.S.A., Inc. 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 Oxoid U.S.A., Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K891593 | LISTERIA SELECTIVE ENRICHMENT MEDIUM | JSI | 81 | |
| K884026 | ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT | GNA | 133 | |
| K884208 | LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION) | KZI | 19 | |
| K874303 | STAPHYLASE TEST | LHT | 17 | |
| K872956 | SORBITOL MACCONKEY AGAR NO. 3 CM 813 | JSI | 12 | |
| K872135 | MCBRIDE MEDIUM CM 819 | JSJ | 12 | |
| K870945 | RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122 | JTL | 93 | |
| K862946 | OXOID SIGNAL BLOOD CULTURE SYSTEM | JSG | 92 | |
| K855236 | DIAGNOSTIC REAGENT TST-RPLA | GTN | 308 | |
| K855235 | DIAGNOSTIC REAGENT PET-RPLA | JSP | 308 |
Source: openFDA device/510k · retrieved
Watch what Oxoid U.S.A., Inc. files next
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