FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TRIGLYCERIDES REAGENT SYSTEM
K Number: K843832
·
Decision Nov 27, 1984
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
150
Applicant Total
8
Review Days
57
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Basic Information
- Device Name
- TRIGLYCERIDES REAGENT SYSTEM
- K Number
- K843832
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1705
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Fermco Biochemics, Inc.
- Date Received
- October 1, 1984
- Decision Date
- November 27, 1984
- 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 Fermco Biochemics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K823106 | RERMCO TEST CHLORIDE REAGENT | Nov 16, 1982 | Substantially Equivalent |
| K822117 | FERMCOTEST CO2 REAGNET | Sep 30, 1982 | Substantially Equivalent |
| K822118 | FERMCOTEST CREATININE TEST REAGENT | Sep 30, 1982 | Substantially Equivalent |
| K810567 | GERMCO TEST R GLUCOSE TEST KIT | Mar 13, 1981 | Substantially Equivalent |
| K791066 | GLUCOSE GOD-PAP TRINDER METHOD TEST KIT | Sep 4, 1979 | Substantially Equivalent |
| K791018 | FERMCOTEST R BUN RATE REAGENT TEST KIT | Jul 17, 1979 | Substantially Equivalent |
| K781945 | GLUCOSE OXIDASE REAGENT | Jan 17, 1979 | Substantially Equivalent |