Biotrack Therapeutic Drug-Monitoring Qual Controls
FDA 510(k) K934062 · Biotrack, Inc.
510(k) numberK934062
Submission
- Device name
- Biotrack Therapeutic Drug-Monitoring Qual Controls
- Applicant
- Biotrack, Inc.
Mountain View, CA, US - Received
- August 19, 1993
- Decision date
- December 29, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DIF – Drug Mixture Control Materials
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.3280
- Specialty
- Clinical Toxicology
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More from Roche Diagnostics Corp.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
Questions and answers
When was Biotrack Therapeutic Drug-Monitoring Qual Controls cleared by the FDA?
Biotrack Therapeutic Drug-Monitoring Qual Controls (K934062) received a 510(k) decision of Substantially Equivalent on December 29, 1993, 132 days after the submission was received.
What is the product code of K934062?
The FDA product code is DIF – Drug Mixture Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.