FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AST REAGENT (PROCEDURE NUMBER 158)
K Number: K892844
·
Decision Jun 20, 1989
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
138
Applicant Total
231
Review Days
63
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Basic Information
- Device Name
- AST REAGENT (PROCEDURE NUMBER 158)
- K Number
- K892844
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1100
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Sigma Chemical Co.
- Date Received
- April 18, 1989
- Decision Date
- June 20, 1989
- 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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