FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RETINOL BINDING RID KIT
K Number: K955881
·
Decision Mar 22, 1996
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
2
Applicant Total
113
Review Days
85
Basic Information
- Device Name
- RETINOL BINDING RID KIT
- K Number
- K955881
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.5765
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- THE BINDING SITE, LTD.
- Date Received
- December 28, 1995
- Decision Date
- March 22, 1996
- Product Code
- CZS
- Advisory Committee
- Immunology
- 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 |
|---|---|---|---|
| CZS | Retinol-Binding Protein, Antigen, Antiserum, Control | FDA class 1 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CZS), ordered by most recent decision date.
RETINOL BINDING PROTEIN RBP RID KIT
FDA 510(k)
FDA Class 1
·Immunology
LASER RBP LASER(RETINOL BINDING PROTEIN REAGENTS)
FDA 510(k)
FDA Class 1
·Immunology
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