Vitros Chemistry Products Caffn Reagent Kit and TDM Performance Verifiers I, II and III
FDA 510(k) K042520 · Ortho-Clinical Diagnostics, Inc.
510(k) numberK042520
Submission
- Device name
- Vitros Chemistry Products Caffn Reagent Kit and TDM Performance Verifiers I, II and III
- Applicant
- Ortho-Clinical Diagnostics, Inc.
Rochester, NY, US - Received
- September 16, 2004
- Decision date
- November 30, 2004
- 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K954569 | Immulite TheophyllineKLS · Traditional | Diagnostic Products Corp. | 11/13/1995SE |
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Questions and answers
When was Vitros Chemistry Products Caffn Reagent Kit and TDM Performance Verifiers I, II and III cleared by the FDA?
Vitros Chemistry Products Caffn Reagent Kit and TDM Performance Verifiers I, II and III (K042520) received a 510(k) decision of Substantially Equivalent on November 30, 2004, 75 days after the submission was received.
What is the product code of K042520?
The FDA product code is KLS – Enzyme Immunoassay, Theophylline, a Class II (moderate risk) device regulated under 21 CFR 862.3880.