FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STABLELIN ENZYME LINERARITY TEST SET A (ITEM NO. 001)
K Number: K965166
·
Decision Feb 4, 1997
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
96
Applicant Total
3
Review Days
42
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Basic Information
- Device Name
- STABLELIN ENZYME LINERARITY TEST SET A (ITEM NO. 001)
- K Number
- K965166
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Specialized Assays, Inc.
- Date Received
- December 24, 1996
- Decision Date
- February 4, 1997
- Product Code
- JJT
- 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 |
|---|---|---|---|
| JJT | Enzyme Controls (Assayed And Unassayed) | FDA class 1 | Clinical Chemistry |
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