FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
B12/FOLATE SING. TUBE DUAL RADIOASSAY KT
K Number: K760946
·
Decision Dec 21, 1976
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
77
Applicant Total
1
Review Days
50
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Basic Information
- Device Name
- B12/FOLATE SING. TUBE DUAL RADIOASSAY KT
- K Number
- K760946
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1810
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Schwarz Mann
- Date Received
- November 1, 1976
- Decision Date
- December 21, 1976
- Product Code
- CDD
- 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 |
|---|---|---|---|
| CDD | Radioassay, Vitamin B12 | FDA class 2 | Clinical Chemistry |
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