Northeast Biomedical Labs., Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Northeast Biomedical Labs., Inc.” (first 1978, latest 1978), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 17 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 |
|---|---|---|---|
| GNS | Antisera, Hai, Influenza Virus A, B, C | 5 | 5 |
| GOK | Antisera, Hai (Including Hai Control), Rubella | 1 | 1 |
| GQQ | Antisera, Hai, Parainfluenza Virus 1-4 | 1 | 1 |
| GQT | Antisera, Cf, Parainfluenza Virus 1-4 | 1 | 1 |
| KIS | Sera, Animal And Human | 1 | 1 |
Review panels
- Microbiology (8)
- Pathology (1)
Most recent Northeast Biomedical Labs., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K780697 | GOAT ANTI-INFLUENZA ANTISERA ATEXAS | GNS | 1978-05-03 | 9 |
| K780696 | GOAT ANTIINFLUENZA ANTISERA AUSSR | GNS | 1978-05-03 | 9 |
| K780010 | GOAT ANTI-RUBELLA ANTISERA | GOK | 1978-01-20 | 17 |
| K780009 | GUINEA PIG WHOLE SERUM | KIS | 1978-01-20 | 17 |
| K780008 | GOAT ANTI-INFLUENZA ANTISERA | GQT | 1978-01-20 | 17 |
| K780007 | GOAT ANTI-INFLUENZA ANTISERA | GQQ | 1978-01-20 | 17 |
| K780006 | GOAT ANTI-INFLUENZA ANTISERA | GNS | 1978-01-20 | 17 |
| K780005 | GOAT ANTI-INFLUENZA ANTISERA | GNS | 1978-01-20 | 17 |
| K780004 | GOAT ANTI-INFLUENZA ANTISERA | GNS | 1978-01-20 | 17 |
Recalls
openFDA lists no recalls under a recalling firm named Northeast Biomedical Labs., 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Northeast Biomedical Labs., Inc. (a text match, not an official crosswalk):
- G0008 — Administration of influenza virus vaccine (via GNS)
- Q2039 — Influenza virus vaccine, not otherwise specified (via GNS)
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.
- Northeast Scientific, Inc. (6 510(k)s)
- Northeast Iowa Podiatry (1 510(k)s)
- Northeast Orthotics and Prothetics, Inc. (1 510(k)s)
- Northeast Resins & Silicones, LLC (1 510(k)s)
- Northeast Scientific, Inc. (Nes) (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Northeast Biomedical Labs., Inc.?
FDA lists 9 510(k) clearances under the applicant name “Northeast Biomedical Labs., Inc.” (first 1978, latest 1978), across 5 product codes in 2 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 Northeast Biomedical Labs., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Northeast Biomedical Labs., Inc. is 17 days.
Which FDA product codes appear under Northeast Biomedical Labs., Inc.?
The most frequent FDA product codes under this applicant name are GNS (Antisera, Hai, Influenza Virus A, B, C, 5); GOK (Antisera, Hai (Including Hai Control), Rubella, 1); GQQ (Antisera, Hai, Parainfluenza Virus 1-4, 1).
Next steps
- See all 9 Northeast Biomedical Labs., Inc. clearances with predicates and recalls
- Run predicate analysis for product code GNS, Northeast Biomedical Labs., 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.