FDA 510(k)
FDA class 1
Substantially Equivalent
🇦🇺 Australia
G.T. (GAMMA-GLUTAMYL TRANSFERASE) REAGENT
K Number: K860723
·
Decision Apr 7, 1986
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
32
Applicant Total
55
Review Days
40
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Basic Information
- Device Name
- G.T. (GAMMA-GLUTAMYL TRANSFERASE) REAGENT
- K Number
- K860723
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1360
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Trace Scientific , Ltd.
- Date Received
- February 26, 1986
- Decision Date
- April 7, 1986
- 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.
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GAMMA-GT
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KING DIAGNOSTICS GAMMA GT REAGENT
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GGT REAGENT
FDA 510(k)
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ROCHE COBAS READY GGT REAGENT
FDA 510(k)
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·Clinical Chemistry
Other Clearances by Trace Scientific , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K982121 | ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT | Sep 17, 1998 | Substantially Equivalent |
| K981123 | UREA | Apr 24, 1998 | Substantially Equivalent |
| K962890 | CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST) | Sep 27, 1996 | Substantially Equivalent |
| K961114 | AST INCORPORATING DST | May 23, 1996 | Substantially Equivalent |
| K961123 | ALT INCORPORATING DST | Apr 25, 1996 | Substantially Equivalent |
| K952488 | TRACE COBAS MIRA RANGE | Oct 13, 1995 | Substantially Equivalent |
| K932713 | TRACE TRANSFERRIN REAGENT | Sep 30, 1993 | Substantially Equivalent |
| K923322 | TRACE ALBUMIN-MR REAGENT | Sep 11, 1992 | Substantially Equivalent |
| K914731 | TRACE GAMMA GT-SS REAGENT | Nov 19, 1991 | Substantially Equivalent |
| K911866 | TRACE TOTAL/DIRECT BILIRUBIN REAGENT | Jul 17, 1991 | Substantially Equivalent |