I.A.F. Production, Inc.: FDA filings under this applicant name
FDA lists 29 510(k) clearances under the applicant name “I.A.F. Production, Inc.” (first 1986, latest 1987), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 35 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JSJ | Culture Media, Selective And Non-Differential | 10 | 10 |
| JSG | Culture Media, Non-Selective And Non-Differential | 5 | 5 |
| JSI | Culture Media, Selective And Differential | 5 | 5 |
| KZI | Culture Media, Enriched | 3 | 3 |
| LKA | Culture Media, Antimicrobial Susceptibility Test | 3 | 3 |
| GMQ | Antigens, Nontreponemal, All | 1 | 1 |
| JSF | Culture Media, Single Biochemical Test | 1 | 1 |
| JSH | Culture Media, Non-Selective And Differential | 1 | 1 |
Review panels
- Microbiology (29)
Most recent I.A.F. Production, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K872690 | IAFP V. AGAR SELECTIVE | JSJ | 1987-09-14 | 69 |
| K872692 | IAFP P.E.A. AGAR W/5% SHEEP BLOOD | JSJ | 1987-08-11 | 35 |
| K872691 | IAFP UREA AGAR SLANT | JSF | 1987-08-11 | 35 |
| K872689 | IAFP SABOURAUD DEXTROSE AGAR | JSJ | 1987-08-11 | 35 |
| K872688 | IAFP MUELLER HINTON AGAR W/5% SHEEP BLOOD | LKA | 1987-08-11 | 35 |
| K872687 | IAFP MUELLER HINTON AGAR W/HEMO. W/CVA ENRICHMENT | LKA | 1987-08-11 | 35 |
| K872686 | IAFP MUELLER HINTON AGAR | LKA | 1987-08-11 | 35 |
| K872685 | IAFP LOWENSTEIN JENSEN SLANT | KZI | 1987-08-11 | 35 |
| K872684 | IAFP CAMPYLOBACTER BLASER | JSJ | 1987-08-11 | 35 |
| K872683 | IAFP BILE ESCULIN AGAR | JSI | 1987-08-11 | 35 |
19 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named I.A.F. Production, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under I.A.F. Production, Inc.?
FDA lists 29 510(k) clearances under the applicant name “I.A.F. Production, Inc.” (first 1986, latest 1987), across 8 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by I.A.F. Production, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name I.A.F. Production, Inc. is 35 days.
Which FDA product codes appear under I.A.F. Production, Inc.?
The most frequent FDA product codes under this applicant name are JSJ (Culture Media, Selective And Non-Differential, 10); JSG (Culture Media, Non-Selective And Non-Differential, 5); JSI (Culture Media, Selective And Differential, 5).
Next steps
- See all 29 I.A.F. Production, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JSJ, I.A.F. Production, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.