FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GAMMA-GLUTAMYL TRANSFERASE DETERMINATION
K Number: K905649
·
Decision Jan 30, 1991
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
51
Applicant Total
20
Review Days
43
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Basic Information
- Device Name
- GAMMA-GLUTAMYL TRANSFERASE DETERMINATION
- K Number
- K905649
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1360
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Biochemical Trade, Inc.
- Date Received
- December 18, 1990
- Decision Date
- January 30, 1991
- 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
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FDA Class 1
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LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SYNCHRON CX SYSTEMS GAMMA-GLUTAMYL TRANSFERASE REAGENT (GGT)
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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 Biochemical Trade, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K942958 | CREATINE KINASE MB DETERMINATION (UV) | Nov 21, 1994 | Substantially Equivalent |
| K910635 | TOTAL BILIRUBIN REAGENT SET | May 15, 1991 | Substantially Equivalent |
| K910296 | PHOSPHORUS (INORGANIC) TEST SYSTEM | Feb 27, 1991 | Substantially Equivalent |
| K905776 | ALBUMIN REAGENT SET | Feb 26, 1991 | Substantially Equivalent |
| K905790 | TOTAL PROTEIN REAGENT SET | Feb 21, 1991 | Substantially Equivalent |
| K905619 | CREATININE (RATE) REAGENT SET | Feb 13, 1991 | Substantially Equivalent |
| K905650 | KINETIC ALKALINE PHOSPHATASE DETERMINATION | Feb 13, 1991 | Substantially Equivalent |
| K905651 | KINETIC AMYLASE DETERMINATION | Jan 31, 1991 | Substantially Equivalent |
| K905588 | CREATINE KINASE UV REAGENT SET | Jan 17, 1991 | Substantially Equivalent |
| K871547 | ULTRA-VIOLET BUN REAGENT KIT (RATE) | Jun 22, 1987 | Substantially Equivalent |