Bio-Analytics Laboratories, Inc.: FDA clearances and approvals
Bio-Analytics Laboratories, Inc. has 19 FDA 510(k) clearances (first 1981, latest 1986), across 18 product codes in 3 review panels. Median 510(k) review time: 21 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 |
|---|---|---|---|
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 2 | 2 |
| CDH | Acid, Uric, Phosphotungstate Reduction | 1 | 1 |
| CDL | Berthelot Indophenol, Urea Nitrogen | 1 | 1 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 | 1 |
| CFA | Electrode, Ion Specific, Magnesium | 1 | 1 |
| CFD | Sulfophosphovanillin, Colorimetry, Total Lipids | 1 | 1 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 | 1 |
| CFM | Bathophenanthroline, Colorimetry, Iron (Non-Heme) | 1 | 1 |
| CIW | Starch-Dye Bound Polymer, Amylase | 1 | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 | 1 |
Plus 8 more product codes.
Review panels
- Clinical Chemistry (16)
- Clinical Toxicology (2)
- Hematology (1)
Most recent Bio-Analytics Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K861638 | KINETIC ALKALINE PHOSPHATASE REAGENT KIT | CJE | 1986-05-29 | 29 |
| K860245 | ENZYMATIC ALPHA-AMYLASE REAGENT KIT | JFJ | 1986-03-14 | 49 |
| K860213 | ALBUMIN REAGENT KIT | CIX | 1986-02-11 | 20 |
| K851514 | ULTRA-VIOLET GLUCOSE REAGENT | CFA | 1985-05-20 | 35 |
| K851513 | ULTRA-VIOLET BUN REAGENT KIT | CDQ | 1985-05-20 | 35 |
| K850639 | ENZYMATIC ALPHA-AMYLASE REAGENT KIT | CIW | 1985-03-05 | 14 |
| K832771 | ERYTHROCYTE TEST | LKZ | 1983-10-28 | 73 |
| K832567 | ACETAMINOPHEN(PARACETAMOL | LDP | 1983-09-12 | 41 |
| K831414 | COLORIMETRIC BUN | CDL | 1983-06-16 | 45 |
| K821934 | BIO-CAL OPERATION CHECK KIT | JIS | 1982-07-20 | 21 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Bio-Analytics 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 Bio-Analytics Laboratories, Inc. have?
Bio-Analytics Laboratories, Inc. has 19 FDA 510(k) clearances (first 1981, latest 1986), across 18 product codes in 3 review panels.
How long does FDA take to clear Bio-Analytics Laboratories, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Bio-Analytics Laboratories, Inc.'s cleared 510(k)s is 21 days.
What devices does Bio-Analytics Laboratories, Inc. make?
Its most frequent FDA product codes are CJE (Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes, 2); CDH (Acid, Uric, Phosphotungstate Reduction, 1); CDL (Berthelot Indophenol, Urea Nitrogen, 1).
Has Bio-Analytics Laboratories, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Bio-Analytics Laboratories, Inc. Related entities may recall under other names.
Next steps
- See all 19 Bio-Analytics Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CJE, Bio-Analytics 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.