FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BINAX PROLACTIN IRMA DIAGNOSTIC KIT
K Number: K880218
·
Decision Mar 1, 1988
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
79
Applicant Total
30
Review Days
41
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Basic Information
- Device Name
- BINAX PROLACTIN IRMA DIAGNOSTIC KIT
- K Number
- K880218
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1625
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Binax, Inc.
- Date Received
- January 20, 1988
- Decision Date
- March 1, 1988
- 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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