FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REAADS PROTEIN S ANTIGEN TEST KIT
K Number: K972482
·
Decision Aug 13, 1997
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
189
Applicant Total
4
Review Days
42
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Basic Information
- Device Name
- REAADS PROTEIN S ANTIGEN TEST KIT
- K Number
- K972482
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7290
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Reaads Medical Products, Inc.
- Date Received
- July 2, 1997
- Decision Date
- August 13, 1997
- 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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