FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FETAL CHECK
K Number: K792546
·
Decision Dec 18, 1979
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
2
Applicant Total
5
Review Days
8
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Basic Information
- Device Name
- FETAL CHECK
- K Number
- K792546
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.1850
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Alta Diagnostics, Inc.
- Date Received
- December 10, 1979
- Decision Date
- December 18, 1979
- Product Code
- KJR
- Advisory Committee
- Hematology
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| KJR | Erythrosin B | FDA class 1 | Hematology |
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