FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TOYO JOZO G-GTP TEST
K Number: K842104
·
Decision Aug 10, 1984
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
32
Applicant Total
13
Review Days
77
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Basic Information
- Device Name
- TOYO JOZO G-GTP TEST
- K Number
- K842104
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1360
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Advocacy International, Ltd.
- Date Received
- May 25, 1984
- Decision Date
- August 10, 1984
- 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
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DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE
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GAMMA-GT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
KING DIAGNOSTICS GAMMA GT REAGENT
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·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 Advocacy International, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
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| K855212 | ASAHI AM SERIES DIALYZERS | Jan 21, 1986 | Substantially Equivalent |
| K854259 | SEPACELL R-500 & SEPACELL R-500A | Jan 8, 1986 | Substantially Equivalent |
| K842103 | TOYO JOZO URIC ACID TEST | Aug 12, 1984 | Substantially Equivalent |
| K830183 | ASAHI HOLLOW FIBER KIDNEYS NR SERIES | Mar 17, 1983 | Substantially Equivalent |
| K830231 | ASAHI HOLLOW FIBER KIDNEYS, AM-SERIES | Mar 17, 1983 | Substantially Equivalent |
| K823733 | EIKEN KIZAI ARTIFICIAL KIDNEY BLOOD CIR | Jan 14, 1983 | Substantially Equivalent |
| K813037 | FLOWGUARD CATHETERS & CANNALAE | Dec 14, 1981 | Substantially Equivalent |