FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ULTRAZYME PLUS GAMMA GT(65055-65056)
K Number: K820233
·
Decision Feb 12, 1982
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
51
Applicant Total
116
Review Days
15
Basic Information
- Device Name
- ULTRAZYME PLUS GAMMA GT(65055-65056)
- K Number
- K820233
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1360
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- HARLECO
- Date Received
- January 28, 1982
- Decision Date
- February 12, 1982
- 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
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Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30
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GAMMA GLUTAMYL TRANSFERASE TEST SYSTEM
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Other Clearances by HARLECO
| K Number | Device Name | ||
|---|---|---|---|
| K813427 | ULTRACHEM GLUC-DH | Dec 31, 1981 | Substantially Equivalent |
| K813043 | ULTRACHEM CREA ITEM #64972 | Nov 10, 1981 | Substantially Equivalent |
| K813039 | ULTRACHEM E-CHOL, ITEM #65025 | Nov 10, 1981 | Substantially Equivalent |
| K813038 | ULTRACHEM TP, ITEM #64974 | Nov 10, 1981 | Substantially Equivalent |
| K813044 | ULTRACHEM ALB, ITEM #64970 | Nov 10, 1981 | Substantially Equivalent |
| K813042 | ULTRACHEM GLUC-DH SET, ITEM #65048 | Nov 10, 1981 | Substantially Equivalent |
| K813041 | ULTRAZYME-GT, ITEM #64959 & 65032 | Nov 10, 1981 | Substantially Equivalent |
| K813040 | ULTRACHEM CA, ITEM #64975 | Nov 10, 1981 | Substantially Equivalent |
| K812593 | ULTRA ZYME PLUS CK-1 #64978, 65027 & 28 | Oct 2, 1981 | Substantially Equivalent |
| K812594 | ULTRA ZYME PLUS AMYL #64982 & 65031 | Oct 2, 1981 | Substantially Equivalent |