FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMX PAP
K Number: K925377
·
Decision Jan 13, 1993
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
44
Applicant Total
857
Review Days
82
Basic Information
- Device Name
- IMX PAP
- K Number
- K925377
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1020
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ABBOTT LABORATORIES
- Date Received
- October 23, 1992
- Decision Date
- January 13, 1993
- Product Code
- JFH
- 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 |
|---|---|---|---|
| JFH | Acid Phosphatase (Prostatic), Tartrate Inhibited | FDA class 2 | Clinical Chemistry |
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