FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT)
K Number: K874903
·
Decision Feb 11, 1988
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
32
Applicant Total
23
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
- MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT)
- K Number
- K874903
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1360
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Simmler, Inc.
- Date Received
- December 1, 1987
- Decision Date
- February 11, 1988
- Product Code
- JPZ
- 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 |
|---|---|---|---|
| JPZ | Colorimetric Method, Gamma-Glutamyl Transpeptidase | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JPZ), ordered by most recent decision date.
CARESIDE GGT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
GAMMA-GT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
KING DIAGNOSTICS GAMMA GT REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
GGT REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ROCHE COBAS READY GGT REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Simmler, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K895745 | SICKLE CELL SOLUBILITY TEST KIT | Nov 29, 1989 | Substantially Equivalent |
| K874595 | MULTICHEM (R) MAGNESIUM REAGENT | Jan 21, 1988 | Substantially Equivalent |
| K874820 | MULTICHEM HDL PRECIPITATING REAGENT #S0914 | Jan 7, 1988 | Substantially Equivalent |
| K874812 | MULTICHEM CHLORIDE REAGENT S0933 | Dec 18, 1987 | Substantially Equivalent |
| K874311 | MULTICHEM (R) TOTAL BILIRUBIN | Nov 25, 1987 | Substantially Equivalent |
| K874049 | MULTICHEM ALBUMIN REAGENT S0902 | Oct 29, 1987 | Substantially Equivalent |
| K874038 | MULTICHEM INORGANIC PHOSPHOROUS S0923 | Oct 28, 1987 | Substantially Equivalent |
| K873725 | MULTICHEM CREATININE REAGENT S0917 | Oct 20, 1987 | Substantially Equivalent |
| K873761 | MULTICHEM ALKALINE PHOSPHATASE (S0903) | Oct 7, 1987 | Substantially Equivalent |
| K873697 | MULTICHEM CALCIUM S0910 | Oct 2, 1987 | Substantially Equivalent |