FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IN VITRO TEST DETERMINATION OF SGPT(ALT)
K Number: K854186
·
Decision Dec 25, 1985
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
126
Applicant Total
36
Review Days
71
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Basic Information
- Device Name
- IN VITRO TEST DETERMINATION OF SGPT(ALT)
- K Number
- K854186
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1030
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Clinical Data, Inc.
- Date Received
- October 15, 1985
- Decision Date
- December 25, 1985
- Product Code
- CKA
- 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 |
|---|---|---|---|
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | FDA class 1 | Clinical Chemistry |
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