FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1
K Number: K944698
·
Decision Mar 21, 1995
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
79
Applicant Total
130
Review Days
179
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Basic Information
- Device Name
- AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1
- K Number
- K944698
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1625
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Organon Teknika Corp.
- Date Received
- September 23, 1994
- Decision Date
- March 21, 1995
- 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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