Biocell Laboratories, Inc.: FDA clearances and approvals
Biocell Laboratories, Inc. has 6 FDA 510(k) clearances (first 1983, latest 2000), across 4 product codes in 2 review panels. Median 510(k) review time: 40 days.
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 company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Biocell Laboratories, Inc. have?
Biocell Laboratories, Inc. has 6 FDA 510(k) clearances (first 1983, latest 2000), across 4 product codes in 2 review panels.
How long does FDA take to clear Biocell Laboratories, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Biocell Laboratories, Inc.'s cleared 510(k)s is 40 days.
What devices does Biocell Laboratories, Inc. make?
Its most frequent FDA product codes are JJX (Single (Specified) Analyte Controls (Assayed And Unassayed), 2); JJY (Multi-Analyte Controls, All Kinds (Assayed), 2); DDG (Transferrin, Antigen, Antiserum, Control, 1).
Has Biocell Laboratories, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Biocell Laboratories, Inc. Related entities may recall under other names.
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. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.