FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
G-GT REAGENT
K Number: K851999
·
Decision Jun 10, 1985
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
51
Applicant Total
33
Review Days
34
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Basic Information
- Device Name
- G-GT REAGENT
- K Number
- K851999
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1360
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Alpkem Corp.
- Date Received
- May 7, 1985
- Decision Date
- June 10, 1985
- 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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ROCHE COBAS IBTEGRA REAGENT CASSETTES
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GAMMA-GLUTAMYL TRANSPEPTIDASE
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FDA Class 1
·Clinical Chemistry
GAMMA GLUTAMYL TRANSFERASE TEST SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Alpkem Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K894011 | TOTAL GALACTOSE | Jan 11, 1990 | Substantially Equivalent |
| K891070 | PHENYLALANINE (NINHYDRIN REACTION) | Oct 27, 1989 | Substantially Equivalent |
| K890334 | TOTAL CHOLESTEROL REAGENT | May 3, 1989 | Substantially Equivalent |
| K890337 | TRIGLYCERIDES - GPO REAGENT | Mar 9, 1989 | Substantially Equivalent |
| K890336 | GLUCOSE (GOD) REAGENT | Feb 27, 1989 | Substantially Equivalent |
| K890332 | RFA/2 RAPID FLOW ANALYZER W/COMPUTER | Feb 17, 1989 | Substantially Equivalent |
| K890335 | SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU. | Feb 17, 1989 | Substantially Equivalent |
| K890333 | ALBUMIN REAGENT | Feb 17, 1989 | Substantially Equivalent |
| K883020 | RFA-300 RAPID FLOW ANALYZER W/COMPUTER | Sep 2, 1988 | Substantially Equivalent |
| K860367 | MAGNESIUM (SUBSTRATE, ENZYME, REAGENT) | Apr 11, 1986 | Substantially Equivalent |