FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IMMO PHASE DIRECT PROGESTERONE RADIO-
K Number: K830880
·
Decision Apr 18, 1983
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
56
Applicant Total
111
Review Days
31
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Basic Information
- Device Name
- IMMO PHASE DIRECT PROGESTERONE RADIO-
- K Number
- K830880
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1620
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Corning Medical & Scientific
- Date Received
- March 18, 1983
- Decision Date
- April 18, 1983
- 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 |
Similar 510(k) Clearances
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