FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GAMMA-GLUTAMYLTRANSFERASE
K Number: K890312
·
Decision Mar 24, 1989
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
51
Applicant Total
73
Review Days
60
Basic Information
- Device Name
- GAMMA-GLUTAMYLTRANSFERASE
- K Number
- K890312
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1360
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- AMERICAN MONITOR CORP.
- Date Received
- January 23, 1989
- Decision Date
- March 24, 1989
- Product Code
- JQB
- 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 |
|---|---|---|---|
| JQB | Kinetic Method, Gamma-Glutamyl Transpeptidase | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
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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 |
| K890034 | PHOTOMETRIC METHOD, IRON (NON-HEME) (75JIY) | Feb 3, 1989 | Substantially Equivalent |
| K883504 | DURAZYME(R) CPK | Sep 13, 1988 | Substantially Equivalent |