FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUANTA-MATE VITAMIN B-12/FOLATE RA
K Number: K771047
·
Decision Jun 27, 1977
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
77
Applicant Total
319
Review Days
17
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Basic Information
- Device Name
- QUANTA-MATE VITAMIN B-12/FOLATE RA
- K Number
- K771047
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1810
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Bio-Rad
- Date Received
- June 10, 1977
- Decision Date
- June 27, 1977
- Product Code
- CDD
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- IM
- 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 |
Similar 510(k) Clearances
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