FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ALT ENZYME ASSAY KIT
K Number: K821946
·
Decision Jul 20, 1982
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
126
Applicant Total
206
Review Days
20
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
- ALT ENZYME ASSAY KIT
- K Number
- K821946
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1030
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Travenol Laboratories, S.A.
- Date Received
- June 30, 1982
- Decision Date
- July 20, 1982
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CKA), ordered by most recent decision date.
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACE ALT REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CARESIDE ALT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
TRACE REAGENT LINE FOR THE COBAS MIRA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Travenol Laboratories, S.A.
| K Number | Device Name | ||
|---|---|---|---|
| K874181 | BAXTER BEDSIDE SYSTEM | Feb 22, 1988 | Substantially Equivalent |
| K873894 | CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITE | Nov 5, 1987 | Substantially Equivalent |
| K873873 | RESUBMITTED MICRON TRANSFUSION FILTER | Oct 22, 1987 | Substantially Equivalent |
| K873984 | AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437) | Oct 20, 1987 | Substantially Equivalent |
| K872364 | HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309 | Oct 13, 1987 | Substantially Equivalent |
| K872652 | UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM | Sep 30, 1987 | Substantially Equivalent |
| K870801 | FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD | Sep 4, 1987 | Substantially Equivalent |
| K871908 | IV ADMINISTRATION SET | Jul 27, 1987 | Substantially Equivalent |
| K871471 | CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15 | Jun 12, 1987 | Substantially Equivalent |
| K865029 | CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER | Apr 17, 1987 | Substantially Equivalent |