Intracel Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Intracel Corp.” (first 1995, latest 2000), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 166 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 |
|---|---|---|---|
| GKZ | Counter, Differential Cell | 1 | 1 |
| GNW | Antisera, Cf, Influenza Virus A, B, C | 1 | 1 |
| GQH | Antigen, Cf (Including Cf Control), Cytomegalovirus | 1 | 1 |
| LLH | Reagents, Clostridium Difficile Toxin | 1 | 1 |
| MJH | Legionella, Spp., Elisa | 1 | 1 |
Review panels
- Microbiology (4)
- Hematology (1)
Most recent Intracel Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K003204 | BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT | GNW | 2000-11-07 | 25 |
| K991074 | BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST | MJH | 1999-12-21 | 265 |
| K990664 | PRIMA SYSTEM - OLD, BARTELS ELISA - NEW | LLH | 1999-03-31 | 30 |
| K982311 | BARTELS CINAKIT CMV ANTIGENEMIA | GQH | 1998-12-14 | 166 |
| K933878 | ZYMMUNE(TM) CD4/CD8 CELL MONITORING KIT | GKZ | 1995-11-14 | 827 |
Recalls
openFDA lists no recalls under a recalling firm named Intracel Corp..
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 Intracel Corp. (a text match, not an official crosswalk):
- G0008 — Administration of influenza virus vaccine (via GNW)
- Q2039 — Influenza virus vaccine, not otherwise specified (via GNW)
- Q2034 — Influenza virus vaccine, split virus, for intramuscular use (agriflu) (via GNW)
Frequently asked questions
How many FDA 510(k) clearances are listed under Intracel Corp.?
FDA lists 5 510(k) clearances under the applicant name “Intracel Corp.” (first 1995, latest 2000), 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 Intracel Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Intracel Corp. is 166 days.
Which FDA product codes appear under Intracel Corp.?
The most frequent FDA product codes under this applicant name are GKZ (Counter, Differential Cell, 1); GNW (Antisera, Cf, Influenza Virus A, B, C, 1); GQH (Antigen, Cf (Including Cf Control), Cytomegalovirus, 1).
Next steps
- See all 5 Intracel Corp. clearances with predicates and recalls
- Run predicate analysis for product code GKZ, Intracel Corp.'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.