FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ALANINE AMINOTRANSFERASE
K Number: K884936
·
Decision Jan 3, 1989
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
126
Applicant Total
41
Review Days
39
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Basic Information
- Device Name
- ALANINE AMINOTRANSFERASE
- K Number
- K884936
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1030
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Catachem, Inc.
- Date Received
- November 25, 1988
- Decision Date
- January 3, 1989
- Product Code
- CKA
- 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 |
|---|---|---|---|
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | FDA class 1 | Clinical Chemistry |
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Other Clearances by Catachem, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K062503 | CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT | Jan 19, 2007 | Substantially Equivalent |
| K945408 | 340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZER | Feb 22, 1995 | Substantially Equivalent |
| K932871 | UIBC FOR DISCREET RANDOM ACCESS ANALYZER | Sep 8, 1993 | Substantially Equivalent |
| 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 |