FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IN VITRO TESTS FOR PHOSPHATASE & BLOOD NITROGEN
K Number: K852441
·
Decision Aug 21, 1985
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
123
Applicant Total
36
Review Days
72
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Basic Information
- Device Name
- IN VITRO TESTS FOR PHOSPHATASE & BLOOD NITROGEN
- K Number
- K852441
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1050
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Clinical Data, Inc.
- Date Received
- June 10, 1985
- Decision Date
- August 21, 1985
- Product Code
- CJE
- 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 |
|---|---|---|---|
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | FDA class 2 | Clinical Chemistry |
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