FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMYLASE FOR MANUAL/AUTOMATED APPLICATIONS
K Number: K902326
·
Decision Jul 31, 1990
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
98
Applicant Total
41
Review Days
68
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- AMYLASE FOR MANUAL/AUTOMATED APPLICATIONS
- K Number
- K902326
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1070
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Catachem, Inc.
- Date Received
- May 24, 1990
- Decision Date
- July 31, 1990
- Product Code
- JFJ
- 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 |
|---|---|---|---|
| JFJ | Catalytic Methods, Amylase | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JFJ), ordered by most recent decision date.
Amylase2
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Atellica CH Amylase_2 (AMY_2)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607
FDA 510(k)
FDA Class 2
·Clinical Chemistry
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 |
| 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 |
| K894476 | CALCIUM (ARSENAZO III) FOR MANUAL/AUTO APPLICATION | Oct 12, 1989 | Substantially Equivalent |