FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
POLI-MAK MODEL F-4 (FINAL
K Number: K820748
·
Decision Apr 6, 1982
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
56
Applicant Total
5
Review Days
18
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Basic Information
- Device Name
- POLI-MAK MODEL F-4 (FINAL
- K Number
- K820748
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2170
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Pm America, Inc.
- Date Received
- March 19, 1982
- Decision Date
- April 6, 1982
- Product Code
- JJF
- 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 |
|---|---|---|---|
| JJF | Analyzer, Chemistry, Micro, For Clinical Use | FDA class 1 | Clinical Chemistry |
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