Genetic Laboratories, Inc.: FDA filings under this applicant name
FDA lists 3 510(k) clearances under the applicant name “Genetic Laboratories, Inc.” (first 1982, latest 1985), plus 1 PMA decision, across 3 product codes in 3 review panels. Median 510(k) review time under this name: 112 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 |
|---|---|---|---|
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 2 | 2 |
| FPX | Strip, Adhesive, Closure, Skin | 1 | 1 |
| MCI | Graft, Vascular, Hemodialysis Access, Synthetic/Biological Composite | 1 | 0 |
Review panels
Most recent Genetic Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K842066 | PERI-GUARD PERICARDIAL PATCH | DXZ | 1985-12-30 | 616 |
| K842621 | SUTURE STRIP | FPX | 1984-10-25 | 112 |
| K821532 | PERIGUARD PERICARDIAL PATCH | DXZ | 1982-08-19 | 87 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P800064 | PMA | BIOFLOW(TM) | 1982-03-10 |
Recalls
openFDA lists no recalls under a recalling firm named Genetic 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.
- Genetic Systems Corp. (12 510(k)s)
- Genetic Testing Institute (6 510(k)s)
- Genetic (1 510(k)s)
- Genetic Laboratories Wound Care, Inc. (1 510(k)s)
- Genetic Signatures Limited (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Genetic Laboratories, Inc.?
FDA lists 3 510(k) clearances under the applicant name “Genetic Laboratories, Inc.” (first 1982, latest 1985), plus 1 PMA decision, across 3 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Genetic Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Genetic Laboratories, Inc. is 112 days.
Which FDA product codes appear under Genetic Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene, 2); FPX (Strip, Adhesive, Closure, Skin, 1); MCI (Graft, Vascular, Hemodialysis Access, Synthetic/Biological Composite, 1).
Next steps
- See all 3 Genetic Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXZ, Genetic 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.