Biotrack, Inc.
Biotrack, Inc. appears in FDA public data with 0 recalls, 16 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on December 29, 1993.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 16
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K934062 | BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLS | December 29, 1993 |
| K934061 | BIOTRACK VALPROIC ACID TEST CARTRIDGE | December 29, 1993 |
| K920525 | BIOTRACK THERAPEUTIC DRUG MONITORING QUAL. CONTROL | August 5, 1992 |
| K915756 | BIOTRACK CARBAMAZEPINE TEST CARTRIDGE | July 23, 1992 |
| K915755 | BIOTRACK PHENYTOIN TEST CARTRIDGE | July 23, 1992 |
| K903924 | BIOTRACK THEOPHYLLINE QUALITY CONTROLS | September 17, 1990 |
| K900373 | BIOTRACK THEOPHYLLINE TEST CARTRIDGE | May 30, 1990 |
| K900372 | BIOTRACK IMMUNOCHEMISTRY MONITOR | February 23, 1990 |
| K895101 | BIOTRACK HEMOGLOBIN TEST CARTRIDGE | October 10, 1989 |
| K895102 | BIOTRACK PDS MONITOR | October 10, 1989 |
| K895128 | BIOTRACK ALT TEST CARTRIDGE | October 6, 1989 |
| K890052 | BIOTRACK APTT REAGENT CARTRIDGE | February 24, 1989 |
| K890051 | BIOTRACK APTT CONTROLS | February 23, 1989 |
| K860719 | BIOTRACK PROTIME CONTROLS (BIOTRACK PROTIME TEST) | May 23, 1986 |
| K860721 | BIOTRACK PROTIME TEST PROTHROMBIN TIME TEST | May 23, 1986 |
| K860720 | BIOTRACK MONITOR (BIOTRACK REAGENT CARTRIDGES) | May 23, 1986 |