Biotrack, Inc.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Biotrack, Inc.” (first 1986, latest 1993), across 14 product codes in 3 review panels. Median 510(k) review time under this name: 86 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 |
|---|---|---|---|
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 3 | 3 |
| CJJ | Diazo, Alt/Sgpt | 1 | 1 |
| DIF | Drug Mixture Control Materials | 1 | 1 |
| DIP | Enzyme Immunoassay, Diphenylhydantoin | 1 | 1 |
| DIS | Enzyme Immunoassay, Barbiturate | 1 | 1 |
| GFO | Activated Partial Thromboplastin | 1 | 1 |
| GIT | Reagent & Control, Partial Thromboplastin Time | 1 | 1 |
| GJS | Test, Time, Prothrombin | 1 | 1 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 1 | 1 |
| KHG | Whole Blood Hemoglobin Determination | 1 | 1 |
Plus 4 more product codes.
Review panels
- Clinical Toxicology (7)
- Hematology (5)
- Clinical Chemistry (4)
Most recent Biotrack, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K934062 | BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLS | DIF | 1993-12-29 | 132 |
| K934061 | BIOTRACK VALPROIC ACID TEST CARTRIDGE | LEG | 1993-12-29 | 132 |
| K920525 | BIOTRACK THERAPEUTIC DRUG MONITORING QUAL. CONTROL | DIS | 1992-08-05 | 183 |
| K915756 | BIOTRACK CARBAMAZEPINE TEST CARTRIDGE | KLT | 1992-07-23 | 213 |
| K915755 | BIOTRACK PHENYTOIN TEST CARTRIDGE | DIP | 1992-07-23 | 213 |
| K903924 | BIOTRACK THEOPHYLLINE QUALITY CONTROLS | LAW | 1990-09-17 | 24 |
| K900373 | BIOTRACK THEOPHYLLINE TEST CARTRIDGE | KLS | 1990-05-30 | 124 |
| K900372 | BIOTRACK IMMUNOCHEMISTRY MONITOR | JJQ | 1990-02-23 | 28 |
| K895102 | BIOTRACK PDS MONITOR | JJQ | 1989-10-10 | 56 |
| K895101 | BIOTRACK HEMOGLOBIN TEST CARTRIDGE | KHG | 1989-10-10 | 56 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Biotrack, 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 Biotrack, Inc.?
FDA lists 16 510(k) clearances under the applicant name “Biotrack, Inc.” (first 1986, latest 1993), across 14 product codes in 3 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 Biotrack, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biotrack, Inc. is 86 days.
Which FDA product codes appear under Biotrack, Inc.?
The most frequent FDA product codes under this applicant name are JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use, 3); CJJ (Diazo, Alt/Sgpt, 1); DIF (Drug Mixture Control Materials, 1).
Next steps
- See all 16 Biotrack, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JJQ, Biotrack, 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.