Theophylline Enzyme Immunoassay
FDA 510(k) K952596 · Diagnostic Reagents, Inc.
510(k) numberK952596
Submission
- Device name
- Theophylline Enzyme Immunoassay
- Applicant
- Diagnostic Reagents, Inc.
Sunnyvale, CA, US - Received
- June 6, 1995
- Decision date
- August 11, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| K961462 | Cedia Theophylline AssayKLS · Traditional | Boehringer Mannheim Corp. | 06/27/1996SE |
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| K972835 | 50NG/ML Cocaine Metabolite CalibratorDLJ · Traditional | 08/28/1997SE |
| K972526 | Methadone Eia AssayDJR · Traditional | 08/04/1997SE |
| K964212 | Quinidine Enzyme ImmunoassayLBZ · Traditional | 12/18/1996SE |
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Questions and answers
When was Theophylline Enzyme Immunoassay cleared by the FDA?
Theophylline Enzyme Immunoassay (K952596) received a 510(k) decision of Substantially Equivalent on August 11, 1995, 66 days after the submission was received.
What is the product code of K952596?
The FDA product code is KLS – Enzyme Immunoassay, Theophylline, a Class II (moderate risk) device regulated under 21 CFR 862.3880.