FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ALT REAGENT (PROCEDURE NUMBER 159)
K Number: K893560
·
Decision Jul 20, 1989
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
126
Applicant Total
231
Review Days
72
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 REAGENT (PROCEDURE NUMBER 159)
- K Number
- K893560
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1030
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Sigma Chemical Co.
- Date Received
- May 9, 1989
- Decision Date
- July 20, 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 |
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 Sigma Chemical Co.
| K Number | Device Name | ||
|---|---|---|---|
| K933694 | SIGMA GLUCOSE REAGENT | Nov 4, 1994 | Substantially Equivalent |
| K933678 | SIGMA CALCIUM REAGENT | Mar 11, 1994 | Substantially Equivalent |
| K933696 | SIGMA ELECTROLYTE REFERENCE REAGENT | Jan 3, 1994 | Substantially Equivalent |
| K933679 | SIGMA BUN REAGENT | Dec 17, 1993 | Substantially Equivalent |
| K933691 | SIGMA CO2 ALKALINE BUFFER REAGENT | Dec 17, 1993 | Substantially Equivalent |
| K933703 | SIGMA WASH CONCENTRATE SOLUTION | Dec 10, 1993 | Substantially Equivalent |
| K933692 | SIGMA CO2 ACID REAGENT | Dec 9, 1993 | Substantially Equivalent |
| K933695 | SIGMA ELECTROLYTE BUFFER | Oct 22, 1993 | Substantially Equivalent |
| K933697 | SIGMA CRE REAGENT | Oct 18, 1993 | Substantially Equivalent |
| K933693 | SIGMA CX-3 CALIBRATION STANDARD LEVEL 2 | Oct 13, 1993 | Substantially Equivalent |