Lerner Laboratories, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Lerner Laboratories, Inc.” (first 1976, latest 1985), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 28 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 |
|---|---|---|---|
| KEM | Agent, Clearing | 2 | 2 |
| LEA | Preservative, Cytological | 2 | 2 |
| KDX | Solution, Decalcifier, Acid Containing | 1 | 1 |
Review panels
- Pathology (5)
Most recent Lerner Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K854083 | XYLENE SUBSTITUTE MONTANT | KEM | 1985-10-22 | 15 |
| K853694 | XYLENE SUBSTITUTE | KEM | 1985-10-22 | 48 |
| K821443 | FORMICAL | KDX | 1982-06-02 | 19 |
| K761001 | PAP-TRAY II (CATALOG #C600-2) | LEA | 1976-12-06 | 28 |
| K761000 | PAP-TRAY I (CATALOG #C600-1) | LEA | 1976-12-06 | 28 |
Recalls
openFDA lists no recalls under a recalling firm named Lerner Laboratories, 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.
- Lerner Medical Devices, Inc. (3 510(k)s)
- Lerner Medical, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Lerner Laboratories, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Lerner Laboratories, Inc.” (first 1976, latest 1985), across 3 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 Lerner Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lerner Laboratories, Inc. is 28 days.
Which FDA product codes appear under Lerner Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are KEM (Agent, Clearing, 2); LEA (Preservative, Cytological, 2); KDX (Solution, Decalcifier, Acid Containing, 1).
Next steps
- See all 5 Lerner Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KEM, Lerner Laboratories, 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.