FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS CALIBRATOR KIT 3
K Number: K001679
·
Decision Jun 28, 2000
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
138
Applicant Total
104
Review Days
27
Basic Information
- Device Name
- VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS CALIBRATOR KIT 3
- K Number
- K001679
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.1100
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Date Received
- June 1, 2000
- Decision Date
- June 28, 2000
- Product Code
- CIT
- 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 |
|---|---|---|---|
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | FDA class 2 | Clinical Chemistry |
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