FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PROGESTERONE KIT
K Number: K810804
·
Decision Apr 1, 1981
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
56
Applicant Total
5
Review Days
8
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Basic Information
- Device Name
- PROGESTERONE KIT
- K Number
- K810804
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1620
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Cambridge Nuclear Corp.
- Date Received
- March 24, 1981
- Decision Date
- April 1, 1981
- Product Code
- JLS
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JLS | Radioimmunoassay, Progesterone | FDA class 1 | Clinical Chemistry |
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