Cedia Theophylline Assay
FDA 510(k) K961462 · Boehringer Mannheim Corp.
510(k) numberK961462
Submission
- Device name
- Cedia Theophylline Assay
- Applicant
- Boehringer Mannheim Corp.
Concord, CA, US - Received
- April 17, 1996
- Decision date
- June 27, 1996
- 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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Questions and answers
When was Cedia Theophylline Assay cleared by the FDA?
Cedia Theophylline Assay (K961462) received a 510(k) decision of Substantially Equivalent on June 27, 1996, 71 days after the submission was received.
What is the product code of K961462?
The FDA product code is KLS – Enzyme Immunoassay, Theophylline, a Class II (moderate risk) device regulated under 21 CFR 862.3880.