Cedia Red Blood Cell Folate (No Boil Reagent Pack)
FDA 510(k) K960800 · Boehringer Mannheim Corp.
510(k) numberK960800
Submission
- Device name
- Cedia Red Blood Cell Folate (No Boil Reagent Pack)
- Applicant
- Boehringer Mannheim Corp.
Concord, CA, US - Received
- February 27, 1996
- Decision date
- July 26, 1996
- 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 Cedia Red Blood Cell Folate (No Boil Reagent Pack) cleared by the FDA?
Cedia Red Blood Cell Folate (No Boil Reagent Pack) (K960800) received a 510(k) decision of Substantially Equivalent on July 26, 1996, 150 days after the submission was received.
What is the product code of K960800?
The FDA product code is CGN – Acid, Folic, Radioimmunoassay, a Class II (moderate risk) device regulated under 21 CFR 862.1295.