Biotrack, Inc.
Medical device manufacturer in Mountain View, CA.
16510(k) clearances
0PMA approvals
0recalls
Device types
- JJQ Colorimeter, Photometer, Spectrophotometer… 3
- JPA System, Multipurpose For In Vitro… 1
- GJS Test, Time, Prothrombin 1
- GIT Reagent & Control, Partial Thromboplastin… 1
- GFO Activated Partial Thromboplastin 1
- CJJ Diazo, Alt/Sgpt 1
- KHG Whole Blood Hemoglobin Determination 1
- KLS Enzyme Immunoassay, Theophylline 1
- LAW Theophylline Control Materials 1
- DIP Enzyme Immunoassay, Diphenylhydantoin 1
- KLT Enzyme Immunoassay, Carbamazepine 1
- DIS Enzyme Immunoassay, Barbiturate 1
- LEG Enzyme Immunoassay, Valproic Acid 1
- DIF Drug Mixture Control Materials 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K934062 | Biotrack Therapeutic Drug-Monitoring Qual ControlsDIF · Traditional | 12/29/1993SE |
| K934061 | Biotrack Valproic Acid Test CartridgeLEG · Traditional | 12/29/1993SE |
| K920525 | Biotrack Therapeutic Drug Monitoring Qual. ControlDIS · Traditional | 08/05/1992SE |
| K915756 | Biotrack Carbamazepine Test CartridgeKLT · Traditional | 07/23/1992SE |
| K915755 | Biotrack Phenytoin Test CartridgeDIP · Traditional | 07/23/1992SE |
| K903924 | Biotrack Theophylline Quality ControlsLAW · Traditional | 09/17/1990SE |
| K900373 | Biotrack Theophylline Test CartridgeKLS · Traditional | 05/30/1990SE |
| K900372 | Biotrack Immunochemistry MonitorJJQ · Traditional | 02/23/1990SE |
| K895102 | Biotrack PDS MonitorJJQ · Traditional | 10/10/1989SE |
| K895101 | Biotrack Hemoglobin Test CartridgeKHG · Traditional | 10/10/1989SE |
| K895128 | Biotrack Alt Test CartridgeCJJ · Traditional | 10/06/1989SE |
| K890052 | Biotrack Aptt Reagent CartridgeGFO · Traditional | 02/24/1989SE |
| K890051 | Biotrack Aptt ControlsGIT · Traditional | 02/23/1989SE |
| K860721 | Biotrack Protime Test Prothrombin Time TestGJS · Traditional | 05/23/1986SE |
| K860720 | Biotrack Monitor (Biotrack Reagent Cartridges)JJQ · Traditional | 05/23/1986SE |
| K860719 | Biotrack Protime Controls (Biotrack Protime Test)JPA · Traditional | 05/23/1986SE |