FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ULTRA ZYME PLUS GAMMA GT #65055 & 56
K Number: K830308
·
Decision Feb 28, 1983
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
51
Applicant Total
62
Review Days
28
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Basic Information
- Device Name
- ULTRA ZYME PLUS GAMMA GT #65055 & 56
- K Number
- K830308
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1360
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Emd Chemicals, Inc.
- Date Received
- January 31, 1983
- Decision Date
- February 28, 1983
- 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
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GAMMA GLUTAMYL TRANSFERASE TEST SYSTEM
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|---|---|---|---|
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| K981926 | ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS | Jul 22, 1998 | Substantially Equivalent |
| K973054 | ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS | Oct 1, 1997 | Substantially Equivalent |
| K951494 | AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR) | Dec 11, 1995 | Substantially Equivalent |
| K951750 | GLUCOSE TEST ITEM NUMBER 97375/94 | Sep 6, 1995 | Substantially Equivalent |
| K950234 | TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2 | Jun 14, 1995 | Substantially Equivalent |
| K950128 | TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2 | May 15, 1995 | Substantially Equivalent |
| K945322 | PHOSPHORUS TEST (PHOS) ITEM NUMBER 65416 | Dec 7, 1994 | Substantially Equivalent |
| K945368 | PHOSPHORUS TEST (PHOS) | Dec 2, 1994 | Substantially Equivalent |