Biocell Laboratories, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Biocell Laboratories, Inc.” (first 1983, latest 2000), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 40 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 |
|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 2 | 2 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 2 | 2 |
| DDG | Transferrin, Antigen, Antiserum, Control | 1 | 1 |
| JIX | Calibrator, Multi-Analyte Mixture | 1 | 1 |
Review panels
- Clinical Chemistry (5)
- Immunology (1)
Most recent Biocell Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K000056 | BIO-LIPID HUMAN SERUM HDL AND LDL CALIBRATORS | JJX | 2000-02-24 | 48 |
| K963551 | BIO-CSF LIQUID CONTROL LEVEL 1 AND 2 | JJX | 1996-10-07 | 32 |
| K951749 | BIO-LIPID LIPID CONTROL- LEVEL 1,2 AND 3 | JJY | 1995-05-15 | 28 |
| K844344 | GEMCAL ENI REFERENCE SERUM | JIX | 1985-01-03 | 55 |
| K830911 | RADIAL IMMUNODIFFUSION PLATES | DDG | 1983-06-10 | 81 |
| K830179 | BIOCELL SPINAL FLUID CONTROL | JJY | 1983-02-18 | 31 |
Recalls
openFDA lists no recalls under a recalling firm named Biocell 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 Biocell Laboratories, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Biocell Laboratories, Inc.” (first 1983, latest 2000), across 4 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 Biocell Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biocell Laboratories, Inc. is 40 days.
Which FDA product codes appear under Biocell Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are JJX (Single (Specified) Analyte Controls (Assayed And Unassayed), 2); JJY (Multi-Analyte Controls, All Kinds (Assayed), 2); DDG (Transferrin, Antigen, Antiserum, Control, 1).
Next steps
- See all 6 Biocell Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JJX, Biocell 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.