Roche Online Theophylline
FDA 510(k) K020740 · Roche Diagnostics Corp.
510(k) numberK020740
Submission
- Device name
- Roche Online Theophylline
- Applicant
- Roche Diagnostics Corp.
Indianapolis, IN, US - Received
- March 6, 2002
- Decision date
- April 16, 2002
- 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
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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 |
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| 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 |
| K954569 | Immulite TheophyllineKLS · Traditional | Diagnostic Products Corp. | 11/13/1995SE |
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Questions and answers
When was Roche Online Theophylline cleared by the FDA?
Roche Online Theophylline (K020740) received a 510(k) decision of Substantially Equivalent on April 16, 2002, 41 days after the submission was received.
What is the product code of K020740?
The FDA product code is KLS – Enzyme Immunoassay, Theophylline, a Class II (moderate risk) device regulated under 21 CFR 862.3880.