FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ENZYMATIC TRIGLYCERIDES-S.V.R.
K Number: K790773
·
Decision Jun 15, 1979
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
150
Applicant Total
41
Review Days
56
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Basic Information
- Device Name
- ENZYMATIC TRIGLYCERIDES-S.V.R.
- K Number
- K790773
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1705
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Calbiochem-Behring Corp.
- Date Received
- April 20, 1979
- Decision Date
- June 15, 1979
- Product Code
- CDT
- 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 |
|---|---|---|---|
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | FDA class 1 | Clinical Chemistry |
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Other Clearances by Calbiochem-Behring Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K831811 | REVOLUTION RADIAL IMMUNODIFFUSION PLATE | Jul 28, 1983 | Substantially Equivalent |
| K831036 | ENA TEST KIT SM & RNP AUTO ANTIBODY | Apr 27, 1983 | Substantially Equivalent |
| K830214 | AFT SYSTEM III | Mar 9, 1983 | Substantially Equivalent |
| K820812 | CREATINE KINASE-MB KIT | Apr 12, 1982 | Substantially Equivalent |
| K813493 | ENZYGNOST TM RUBELLA IGM | Mar 4, 1982 | Substantially Equivalent |
| K820088 | AFT SYSTEM PROFICIENCY TESTING PROGRAM | Jan 26, 1982 | Substantially Equivalent |
| K812458 | PADAC | Sep 23, 1981 | Substantially Equivalent |
| K810718 | C-PEPTICE REAGENTS | Mar 31, 1981 | Substantially Equivalent |
| K810669 | PANTRAK E.K. | Mar 31, 1981 | Substantially Equivalent |
| K810309 | RUBELLA ANTIBODIES TEST REAGENTS | Mar 11, 1981 | Substantially Equivalent |