Accumeter Theophylline Test
FDA 510(k) K972495 · Chemtrak, Inc.
510(k) numberK972495
Submission
- Device name
- Accumeter Theophylline Test
- Applicant
- Chemtrak, Inc.
Sunnyvale, CA, US - Received
- July 3, 1997
- Decision date
- October 10, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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
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|---|---|---|---|
| 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 |
| K961462 | Cedia Theophylline AssayKLS · Traditional | Boehringer Mannheim Corp. | 06/27/1996SE |
| K954569 | Immulite TheophyllineKLS · Traditional | Diagnostic Products Corp. | 11/13/1995SE |
More from Diagnostic Products Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K965099 | Accumeter H. Pylori TestLYR · Traditional | 02/20/1997SE |
| K960478 | Accumeter H. Pylori TestLYR · Traditional | 06/27/1996SE |
| K943279 | Accumeter HDL Cholesterol TestLBS · Traditional | 05/01/1995SE |
| K943599 | Chem Trak AccumeterCHH · Traditional | 03/21/1995SE |
| K914432 | Accumeter(R) Cholesterol Self-TestCHH · Traditional | 03/02/1993SE |
| K905405 | Chemtrak Accumeter Cholesterol TestCHH · Traditional | 03/19/1991SE |
Questions and answers
When was Accumeter Theophylline Test cleared by the FDA?
Accumeter Theophylline Test (K972495) received a 510(k) decision of Substantially Equivalent on October 10, 1997, 99 days after the submission was received.
What is the product code of K972495?
The FDA product code is KLS – Enzyme Immunoassay, Theophylline, a Class II (moderate risk) device regulated under 21 CFR 862.3880.