Nolan Biological Laboratories, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Nolan Biological Laboratories, Inc.” (first 1980, latest 1981), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 53 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 |
|---|---|---|---|
| GMI | Antigen, Cf And / Or Id, Coccidioides Immitis | 1 | 1 |
| GMJ | Antigens, Histoplasma Capsulatum, All | 1 | 1 |
| JWT | Antigen, Cf, Aspergillus Spp. | 1 | 1 |
| JWW | Antigen, Cf, B. Dermatitidis | 1 | 1 |
| LHK | Antigen, Id, Candida Albicans | 1 | 1 |
Review panels
- Microbiology (5)
Most recent Nolan Biological Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K812741 | REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS | LHK | 1981-10-23 | 24 |
| K812740 | REAGENTS FOR SERODIAGNOSIS OF ASPERGILL | JWT | 1981-10-20 | 21 |
| K802130 | IMMUNO. IDENTIFICATION OF H. CAPSULATUM | GMJ | 1980-09-26 | 53 |
| K802129 | IMMUNODIFFUSION REAGENTS/SEROLOGICAL | GMI | 1980-09-26 | 53 |
| K802128 | IMMUNODIFFUSSION REAGENTS/SEROLOGICAL | JWW | 1980-09-26 | 53 |
Recalls
openFDA lists no recalls under a recalling firm named Nolan Biological 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Nolan Biological Laboratories, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Nolan Biological Laboratories, Inc.” (first 1980, latest 1981), across 5 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 Nolan Biological Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nolan Biological Laboratories, Inc. is 53 days.
Which FDA product codes appear under Nolan Biological Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are GMI (Antigen, Cf And / Or Id, Coccidioides Immitis, 1); GMJ (Antigens, Histoplasma Capsulatum, All, 1); JWT (Antigen, Cf, Aspergillus Spp., 1).
Next steps
- See all 5 Nolan Biological Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GMI, Nolan Biological 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.