FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AMERLITE PROLACTIN-30 ASSAY
K Number: K922170
·
Decision Sep 2, 1992
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
79
Applicant Total
238
Review Days
117
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Basic Information
- Device Name
- AMERLITE PROLACTIN-30 ASSAY
- K Number
- K922170
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1625
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Eastman Kodak Company
- Date Received
- May 8, 1992
- Decision Date
- September 2, 1992
- Product Code
- CFT
- 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 |
|---|---|---|---|
| CFT | Radioimmunoassay, Prolactin (Lactogen) | FDA class 1 | Clinical Chemistry |
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| K042158 | KODAK MEDICAL IMAGER 300 | Sep 24, 2004 | Substantially Equivalent |
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