FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AURAFLEX PROGESTERONE 150TEST PACK
K Number: K951630
·
Decision May 8, 1995
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
56
Applicant Total
130
Review Days
31
Basic Information
- Device Name
- AURAFLEX PROGESTERONE 150TEST PACK
- K Number
- K951630
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1620
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ORGANON TEKNIKA CORP.
- Date Received
- April 7, 1995
- Decision Date
- May 8, 1995
- 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
Other 510(k) clearances with the same product code (JLS), ordered by most recent decision date.
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