FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
KING DIAGNOSTICS GAMMA GT REAGENT
K Number: K923091
·
Decision Sep 9, 1992
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
32
Applicant Total
41
Review Days
76
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Basic Information
- Device Name
- KING DIAGNOSTICS GAMMA GT REAGENT
- K Number
- K923091
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1360
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- King Diagnostics, Inc.
- Date Received
- June 25, 1992
- Decision Date
- September 9, 1992
- 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 |
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ELITECH GAMMA GT TEST KIT
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Other Clearances by King Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K933329 | KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENT | Oct 22, 1993 | Substantially Equivalent |
| K931834 | KING SODIUM/POTASSIUM STANDARD MODIFIED | Aug 25, 1993 | Substantially Equivalent |
| K931773 | HDL PRECIPITATING REAGENT (DEXTRAN SULFATE) | Aug 16, 1993 | Substantially Equivalent |
| K931326 | KING DIAGNOSTICS CK REAGENT | Jun 15, 1993 | Substantially Equivalent |
| K923129 | KING DIAGNOSTICS GLUCOSE (HK) REAGENT | Nov 2, 1992 | Substantially Equivalent |
| K922969 | KING DIAGNOSTICS UREA NITROGEN REAGENT | Oct 13, 1992 | Substantially Equivalent |
| K922921 | KING DIAGNOSTICS CHLORIDE REAGENT | Oct 5, 1992 | Substantially Equivalent |
| K923927 | KING DIAGNOSTICS MAGNESIUM REAGENT | Sep 30, 1992 | Substantially Equivalent |
| K923128 | KING DIAGNOSTICS CHOLESTEROL REAGENT | Sep 9, 1992 | Substantially Equivalent |
| K922964 | KING DIAGNOSTIC TRIGLYCERIDES REAGENT | Aug 18, 1992 | Substantially Equivalent |