Baker TDM Theophylline Assay
FDA 510(k) K873596 · Baker Instructions Corp.
510(k) numberK873596
Submission
- Device name
- Baker TDM Theophylline Assay
- Applicant
- Baker Instructions Corp.
Winchester, VA, US - Received
- September 4, 1987
- Decision date
- October 20, 1987
- 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 |
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| K850386 | System 8000 Cell CounterGKL · Traditional | 05/02/1985SE |
| K833116 | Spirit Chemistry SystemJJE · Traditional | 11/07/1983SE |
| K832716 | Encore Chemistry AnalyzerJJG · Traditional | 10/04/1983SE |
| K830641 | Encore Chemistry AnalyzerJJG · Traditional | 04/05/1983SE |
| K821956 | Haem-C Plus Blood Reference ControlsJCN · Traditional | 07/30/1982SE |
| K811694 | Centrifichem Alt/Agpt Optimized ReagentCKA · Traditional | 07/01/1981SE |
Questions and answers
When was Baker TDM Theophylline Assay cleared by the FDA?
Baker TDM Theophylline Assay (K873596) received a 510(k) decision of Substantially Equivalent on October 20, 1987, 46 days after the submission was received.
What is the product code of K873596?
The FDA product code is KLS – Enzyme Immunoassay, Theophylline, a Class II (moderate risk) device regulated under 21 CFR 862.3880.