Access Theophylline Immunoassay Reagents
FDA 510(k) K922823 · Bio-Rad Laboratories, Inc.
510(k) numberK922823
Submission
- Device name
- Access Theophylline Immunoassay Reagents
- Applicant
- Bio-Rad Laboratories, Inc.
Chaska, MN, US - Received
- June 11, 1992
- Decision date
- August 5, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CGN – Acid, Folic, Radioimmunoassay
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1295
- Specialty
- Clinical Chemistry
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Questions and answers
When was Access Theophylline Immunoassay Reagents cleared by the FDA?
Access Theophylline Immunoassay Reagents (K922823) received a 510(k) decision of Substantially Equivalent on August 5, 1992, 55 days after the submission was received.
What is the product code of K922823?
The FDA product code is CGN – Acid, Folic, Radioimmunoassay, a Class II (moderate risk) device regulated under 21 CFR 862.1295.