Biotrack Theophylline Test Cartridge
FDA 510(k) K900373 · Biotrack, Inc.
510(k) numberK900373
Submission
- Device name
- Biotrack Theophylline Test Cartridge
- Applicant
- Biotrack, Inc.
Mountain View, CA, US - Received
- January 26, 1990
- Decision date
- May 30, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KLS – Enzyme Immunoassay, Theophylline
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3880
- Specialty
- Clinical Toxicology
Other 510(k)s with product code KLS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K042520 | Vitros Chemistry Products Caffn Reagent Kit and TDM Performance Verifiers I, II and IIIKLS · Traditional | Ortho-Clinical Diagnostics, Inc. | 11/30/2004SE |
| K042407 | Emit Caffeine AssayKLS · Traditional | Dade Behring, Inc. | 10/28/2004SE |
| K020740 | Roche Online TheophyllineKLS · Traditional | Roche Diagnostics Corp. | 04/16/2002SE |
| K011771 | Randox TheophyllineKLS · Traditional | Randox Laboratories, Ltd. | 01/17/2002SE |
| K013272 | Acs: 180 and Advia Centaur Theophylline 2 AssayKLS · Special | Bayer Corp. | 10/25/2001SE |
| K011166 | Modification to Emit 2000 Theophylline Assay, Model Osr 4P229KLS · Special | Syva Co., Dade Behring, Inc. | 05/10/2001SE |
| K993029 | Abbott Aeroset Theophylline Assay and Calibrators; Models 1E09 and 6E89KLS · Traditional | Syva Co. | 01/27/2000SE |
| K973583 | Ace Theophylline Reagent, Theo CalibratorsKLS · Traditional | Schiapparelli Biosystems, Inc. | 11/12/1997SE |
| K972495 | Accumeter Theophylline TestKLS · Traditional | Chemtrak, Inc. | 10/10/1997SE |
| K961462 | Cedia Theophylline AssayKLS · Traditional | Boehringer Mannheim Corp. | 06/27/1996SE |
More from Boehringer Mannheim Corp.
| 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 |
| 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 Theophylline Test Cartridge cleared by the FDA?
Biotrack Theophylline Test Cartridge (K900373) received a 510(k) decision of Substantially Equivalent on May 30, 1990, 124 days after the submission was received.
What is the product code of K900373?
The FDA product code is KLS – Enzyme Immunoassay, Theophylline, a Class II (moderate risk) device regulated under 21 CFR 862.3880.