FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ASPARTATE AMINOTRANSFERASE (AST)/(GOT)
K Number: K870077
·
Decision Mar 6, 1987
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
138
Applicant Total
41
Review Days
57
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Basic Information
- Device Name
- ASPARTATE AMINOTRANSFERASE (AST)/(GOT)
- K Number
- K870077
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1100
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Catachem, Inc.
- Date Received
- January 8, 1987
- Decision Date
- March 6, 1987
- 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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|---|---|---|---|
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| K903341 | MAGNESIUM | Aug 22, 1990 | Substantially Equivalent |
| K902326 | AMYLASE FOR MANUAL/AUTOMATED APPLICATIONS | Jul 31, 1990 | Substantially Equivalent |
| K902877 | TOTAL IRON FOR MANUAL/AUTOMATED | Jul 27, 1990 | Substantially Equivalent |
| K895748 | BICARBONATE FOR MANUAL/AUTOMATED APPLICATIONS | Dec 21, 1989 | Substantially Equivalent |
| K895821 | URIC ACID FOR MANUAL/AUTOMATED APPLICATIONS | Dec 5, 1989 | Substantially Equivalent |
| K894715 | CREATINE KINASE FOR MANUAL/AUTOMATED APPLICATIONS | Nov 8, 1989 | Substantially Equivalent |
| K894389 | CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS | Oct 12, 1989 | Substantially Equivalent |