FDA 510(k)
Substantially Equivalent
🇺🇸 United States
Y-GLUTAMYLTRANSFERASE
K Number: K813215
·
Decision Dec 8, 1981
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
73
Review Days
29
Basic Information
- Device Name
- Y-GLUTAMYLTRANSFERASE
- K Number
- K813215
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- AMERICAN MONITOR CORP.
- Date Received
- November 9, 1981
- Decision Date
- December 8, 1981
- Advisory Committee
- Unknown
- Review Advisory Committee
- CH
- Third Party
- N
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| K Number | Device Name | ||
|---|---|---|---|
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| 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 |