FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DURAZYME GOT/AST
K Number: K792208
·
Decision Nov 27, 1979
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
138
Applicant Total
73
Review Days
25
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Basic Information
- Device Name
- DURAZYME GOT/AST
- K Number
- K792208
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1100
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- American Monitor Corp.
- Date Received
- November 2, 1979
- Decision Date
- November 27, 1979
- 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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Other Clearances by American Monitor Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K895999 | PHOSPHORUS | Jan 11, 1990 | Substantially Equivalent |
| K896000 | ASPARTATE AMINOTRANFERASE (AST) | Jan 11, 1990 | Substantially Equivalent |
| K896001 | ALANINE AMINOTRANSFERASE (ALT) | Nov 13, 1989 | Substantially Equivalent |
| K895423 | ACCESS CHEMISTRY ANALYZER | Oct 4, 1989 | Substantially Equivalent |
| K893137 | EXCEL (TM) CHEMISTRY ANALYZER | Aug 10, 1989 | Substantially Equivalent |
| K892331 | ENZYMATIC UREA NITROGEN REAGENT SET | Jun 20, 1989 | Substantially Equivalent |
| K893479 | CHOLESTEROL REAGENT SET | Jun 19, 1989 | Substantially Equivalent |
| K892002 | NEOCHROME(R) III GLUCOSE | Jun 12, 1989 | Substantially Equivalent |
| K890312 | GAMMA-GLUTAMYLTRANSFERASE | Mar 24, 1989 | Substantially Equivalent |
| K890034 | PHOTOMETRIC METHOD, IRON (NON-HEME) (75JIY) | Feb 3, 1989 | Substantially Equivalent |