FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VARIANT SICKLE CELL SHORT PROGRAM
K Number: K924813
·
Decision Jan 14, 1993
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
22
Applicant Total
318
Review Days
111
Basic Information
- Device Name
- VARIANT SICKLE CELL SHORT PROGRAM
- K Number
- K924813
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7415
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- BIO-RAD
- Date Received
- September 25, 1992
- Decision Date
- January 14, 1993
- Product Code
- GKA
- 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 |
|---|---|---|---|
| GKA | Abnormal Hemoglobin Quantitation | FDA class 2 | Hematology |
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