Biotrack Alt Test Cartridge
FDA 510(k) K895128 · Biotrack, Inc.
510(k) numberK895128
Submission
- Device name
- Biotrack Alt Test Cartridge
- Applicant
- Biotrack, Inc.
Mountain View, CA, US - Received
- August 17, 1989
- Decision date
- October 6, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CJJ – Diazo, Alt/Sgpt
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1030
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CJJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K943003 | Calcium QvetCJJ · Traditional | Prisma Systems | 12/09/1994SE |
More from Prisma Systems
| 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 |
Questions and answers
When was Biotrack Alt Test Cartridge cleared by the FDA?
Biotrack Alt Test Cartridge (K895128) received a 510(k) decision of Substantially Equivalent on October 6, 1989, 50 days after the submission was received.
What is the product code of K895128?
The FDA product code is CJJ – Diazo, Alt/Sgpt, a Class I (low risk) device regulated under 21 CFR 862.1030.