FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GGT REAGENTS, 7738, 7739, 7538, 7438 & 7138
K Number: K905096
·
Decision Nov 28, 1990
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
51
Applicant Total
39
Review Days
15
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
- GGT REAGENTS, 7738, 7739, 7538, 7438 & 7138
- K Number
- K905096
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1360
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Amresco, Inc.
- Date Received
- November 13, 1990
- Decision Date
- November 28, 1990
- Product Code
- JQB
- 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 |
|---|---|---|---|
| JQB | Kinetic Method, Gamma-Glutamyl Transpeptidase | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JQB), ordered by most recent decision date.
Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SYNCHRON CX SYSTEMS GAMMA-GLUTAMYL TRANSFERASE REAGENT (GGT)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ROCHE COBAS IBTEGRA REAGENT CASSETTES
FDA 510(k)
FDA Class 1
·Clinical Chemistry
GAMMA-GLUTAMYL TRANSPEPTIDASE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
GAMMA GLUTAMYL TRANSFERASE TEST SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Amresco, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K905618 | GGT REAGENT | Feb 26, 1991 | Substantially Equivalent |
| K904468 | DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/7176 | Jan 17, 1991 | Substantially Equivalent |
| K905684 | ALKALINE PHOSPHATASE | Dec 28, 1990 | Substantially Equivalent |
| K905544 | MAGNESIUM REAGENT | Dec 27, 1990 | Substantially Equivalent |
| K905284 | HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173 | Dec 11, 1990 | Substantially Equivalent |
| K904004 | AMRESCOCREAT KINASE REAGENT 7716/17,7516,7416,7116 | Dec 11, 1990 | Substantially Equivalent |
| K904381 | DIAZO COLORIMENTRY DIRECT BILIRUBIN | Oct 12, 1990 | Substantially Equivalent |
| K903775 | CREATINE PHOSPHOKINASE | Oct 4, 1990 | Substantially Equivalent |
| K903829 | AST REAGENT | Sep 25, 1990 | Substantially Equivalent |
| K904007 | BICARBONATE REAGENTS AMRESCO PRODUCT #4326020 | Sep 13, 1990 | Substantially Equivalent |