FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CEDIA RED BLOOD CELL FOLATE (NO BOIL REAGENT PACK)
K Number: K960800
·
Decision Jul 26, 1996
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
63
Applicant Total
340
Review Days
150
Basic Information
- Device Name
- CEDIA RED BLOOD CELL FOLATE (NO BOIL REAGENT PACK)
- K Number
- K960800
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1295
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BOEHRINGER MANNHEIM CORP.
- Date Received
- February 27, 1996
- Decision Date
- July 26, 1996
- Product Code
- CGN
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CGN | Acid, Folic, Radioimmunoassay | FDA class 2 | Clinical Chemistry |
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