Biotrack Phenytoin Test Cartridge
FDA 510(k) K915755 · Biotrack, Inc.
510(k) numberK915755
Submission
- Device name
- Biotrack Phenytoin Test Cartridge
- Applicant
- Biotrack, Inc.
Mountain View, CA, US - Received
- December 23, 1991
- Decision date
- July 23, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DIP – Enzyme Immunoassay, Diphenylhydantoin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3350
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DIP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K080696 | Architect Iphenytoin Reagents and Architech Iphenytoin Calibrators with Models 1P34, and…DIP · Traditional | Abbott Laboratories | 09/11/2008SE |
| K063145 | Phenobarbital, Phenytoin, TDM Calibration Set B and Abtrol/Nortrol ControlsDIP · Traditional | Thermo Electron OY | 10/17/2007SE |
| K030428 | Roche Online TDM PhenytoinDIP · Traditional | Roche Diagnostics Corp. | 04/28/2003SE |
| K011393 | Randox PhenytoinDIP · Traditional | Randox Laboratories, Ltd. | 12/04/2001SE |
| K011347 | Emit 2000 Phenytoin Assay, Model 0SR4A229DIP · Special | Syva Co. | 05/17/2001SE |
| K000006 | Immulite Phenytoin, Immulite 2000 Phenytoin, Catalog # LKPN1, LKPN5 & L2KPN2, L2KPN6DIP · Traditional | Diagnostic Products Corp. | 02/28/2000SE |
| K993026 | Abbot Aeroset Phenytoin Assay & Abbot Aeroset Phenytoin CalibratorsDIP · Traditional | Syva Co. | 01/27/2000SE |
| K973414 | Ace Phenytoin Reagent, AED CalibratorsDIP · Traditional | Schiapparelli Biosystems, Inc. | 11/04/1997SE |
| K963840 | Cedia Phenytoin II AssayDIP · Traditional | Boehringer Mannheim Corp. | 11/20/1996SE |
| K943980 | Il Test Phenytion CalibratorsDIP · Traditional | Instrumentation Laboratory CO | 05/01/1995SE |
More from Instrumentation Laboratory CO
| 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 |
| 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 Phenytoin Test Cartridge cleared by the FDA?
Biotrack Phenytoin Test Cartridge (K915755) received a 510(k) decision of Substantially Equivalent on July 23, 1992, 213 days after the submission was received.
What is the product code of K915755?
The FDA product code is DIP – Enzyme Immunoassay, Diphenylhydantoin, a Class II (moderate risk) device regulated under 21 CFR 862.3350.