FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STACLOT(R) PROTEIN S TEST KIT
K Number: K913424
·
Decision Oct 8, 1991
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
188
Applicant Total
79
Review Days
68
Basic Information
- Device Name
- STACLOT(R) PROTEIN S TEST KIT
- K Number
- K913424
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7290
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- AMERICAN BIOPRODUCTS CO.
- Date Received
- August 1, 1991
- Decision Date
- October 8, 1991
- Product Code
- GGP
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| GGP | Test, Qualitative And Quantitative Factor Deficiency | FDA class 2 | Hematology |
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