Lakewood Biochemical Co., Inc.: FDA filings under this applicant name
FDA lists 89 510(k) clearances under the applicant name “Lakewood Biochemical Co., Inc.” (first 1987, latest 1988), across 10 product codes in 1 review panel. Median 510(k) review time under this name: 39 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 | 30 | 30 |
| JSG | Culture Media, Non-Selective And Non-Differential | 28 | 28 |
| JSI | Culture Media, Selective And Differential | 14 | 14 |
| KZI | Culture Media, Enriched | 6 | 6 |
| JSD | Culture Media, Selective Broth | 3 | 3 |
| JSH | Culture Media, Non-Selective And Differential | 3 | 3 |
| JSF | Culture Media, Single Biochemical Test | 2 | 2 |
| JSE | Culture Media, Multiple Biochemical Test | 1 | 1 |
| JTS | Stains, Microbiologic | 1 | 1 |
| JTZ | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | 1 | 1 |
Review panels
- Microbiology (89)
Most recent Lakewood Biochemical Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K882495 | THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007 | JSG | 1988-07-01 | 15 |
| K882351 | MUELLER HINTON AGAR PLATES P3318/1&2/P3418/P34181 | JTZ | 1988-06-28 | 21 |
| K882463 | POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421 | JSJ | 1988-06-22 | 7 |
| K882182 | SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P3326 | JSI | 1988-06-06 | 13 |
| K880947 | NUTRIENT AGAR PLATE, SLANT TUBE AND BROTH TUBE | JSG | 1988-04-01 | 25 |
| K880946 | NUTRIENT GELATIN - PRODUCT NUMBER T2860 | JSF | 1988-04-01 | 25 |
| K880945 | CAMPLYOBACTER CULTURE MEDIA PRODUCTS P3873/T3597 | JSJ | 1988-03-30 | 23 |
| K875136 | COLUMBIA BLOOD AGAR P3308/ COLUMBIA CNA P3750 | JSG | 1988-01-12 | 28 |
| K874538 | TODD-HEWITT BROTH (0.5ML)#3099 & (5.OML)#T3516 | JSG | 1987-11-20 | 17 |
| K874537 | KLIGLER IRON AGAR AND TRIPLE SUGAR IRON AGAR | JSE | 1987-11-20 | 17 |
79 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Lakewood Biochemical Co., 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Lakewood Ent., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Lakewood Biochemical Co., Inc.?
FDA lists 89 510(k) clearances under the applicant name “Lakewood Biochemical Co., Inc.” (first 1987, latest 1988), across 10 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 Lakewood Biochemical Co., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lakewood Biochemical Co., Inc. is 39 days.
Which FDA product codes appear under Lakewood Biochemical Co., Inc.?
The most frequent FDA product codes under this applicant name are JSJ (Culture Media, Selective And Non-Differential, 30); JSG (Culture Media, Non-Selective And Non-Differential, 28); JSI (Culture Media, Selective And Differential, 14).
Next steps
- See all 89 Lakewood Biochemical Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code JSJ, Lakewood Biochemical Co., 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.