FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACCESS VITAMIN B12 ASSAY
K Number: K933142
·
Decision Nov 5, 1993
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
77
Applicant Total
82
Review Days
130
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Basic Information
- Device Name
- ACCESS VITAMIN B12 ASSAY
- K Number
- K933142
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1810
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bio-Rad Laboratories, Inc.
- Date Received
- June 28, 1993
- Decision Date
- November 5, 1993
- 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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