Company ยท US
Biotrack, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1986 to 1993. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 3 |
| CJJ | Diazo, Alt/Sgpt | 1 |
| DIF | Drug Mixture Control Materials | 1 |
| DIP | Enzyme Immunoassay, Diphenylhydantoin | 1 |
| DIS | Enzyme Immunoassay, Barbiturate | 1 |
| GFO | Activated Partial Thromboplastin | 1 |
| GIT | Reagent & Control, Partial Thromboplastin Time | 1 |
| GJS | Test, Time, Prothrombin | 1 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 1 |
| KHG | Whole Blood Hemoglobin Determination | 1 |
| KLS | Enzyme Immunoassay, Theophylline | 1 |
| KLT | Enzyme Immunoassay, Carbamazepine | 1 |
| LAW | Theophylline Control Materials | 1 |
| LEG | Enzyme Immunoassay, Valproic Acid | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 29, 1993 | K934062 | BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLS Biotrack, Inc. | DIF |
| Dec 29, 1993 | K934061 | BIOTRACK VALPROIC ACID TEST CARTRIDGE Biotrack, Inc. | LEG |
| Aug 5, 1992 | K920525 | BIOTRACK THERAPEUTIC DRUG MONITORING QUAL. CONTROL Biotrack, Inc. | DIS |
| Jul 23, 1992 | K915756 | BIOTRACK CARBAMAZEPINE TEST CARTRIDGE Biotrack, Inc. | KLT |
| Jul 23, 1992 | K915755 | BIOTRACK PHENYTOIN TEST CARTRIDGE Biotrack, Inc. | DIP |
| Sep 17, 1990 | K903924 | BIOTRACK THEOPHYLLINE QUALITY CONTROLS Biotrack, Inc. | LAW |
| May 30, 1990 | K900373 | BIOTRACK THEOPHYLLINE TEST CARTRIDGE Biotrack, Inc. | KLS |
| Feb 23, 1990 | K900372 | BIOTRACK IMMUNOCHEMISTRY MONITOR Biotrack, Inc. | JJQ |
| Oct 10, 1989 | K895102 | BIOTRACK PDS MONITOR Biotrack, Inc. | JJQ |
| Oct 10, 1989 | K895101 | BIOTRACK HEMOGLOBIN TEST CARTRIDGE Biotrack, Inc. | KHG |
| Oct 6, 1989 | K895128 | BIOTRACK ALT TEST CARTRIDGE Biotrack, Inc. | CJJ |
| Feb 24, 1989 | K890052 | BIOTRACK APTT REAGENT CARTRIDGE Biotrack, Inc. | GFO |
| Feb 23, 1989 | K890051 | BIOTRACK APTT CONTROLS Biotrack, Inc. | GIT |
| May 23, 1986 | K860721 | BIOTRACK PROTIME TEST PROTHROMBIN TIME TEST Biotrack, Inc. | GJS |
| May 23, 1986 | K860720 | BIOTRACK MONITOR (BIOTRACK REAGENT CARTRIDGES) Biotrack, Inc. | JJQ |
| May 23, 1986 | K860719 | BIOTRACK PROTIME CONTROLS (BIOTRACK PROTIME TEST) Biotrack, Inc. | JPA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||