FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TRIGLYCERIDE REAGENT SET
K Number: K812838
·
Decision Dec 3, 1981
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
150
Applicant Total
26
Review Days
55
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Basic Information
- Device Name
- TRIGLYCERIDE REAGENT SET
- K Number
- K812838
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1705
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Anco Medical Reagents & Assoc.
- Date Received
- October 9, 1981
- Decision Date
- December 3, 1981
- 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 Anco Medical Reagents & Assoc.
| K Number | Device Name | ||
|---|---|---|---|
| K842440 | SICKLE CELL STAT A/S HETEROZYGOUS-ERYTH | Jul 27, 1984 | Substantially Equivalent |
| K831871 | SICKLE-HEME A/S CONTROLS & A/A CONTROL | Jul 28, 1983 | Substantially Equivalent |
| K821658 | HEMOGLOBIN REAGENT | Jun 25, 1982 | Substantially Equivalent |
| K821526 | ACID PHOSPHATASE REAGENT SET | Jun 10, 1982 | Substantially Equivalent |
| K821102 | MEGNESIUM REAGENT KIT | May 5, 1982 | Substantially Equivalent |
| K820951 | ENZYMATIC CHOLESTEROL KIT | Apr 26, 1982 | Substantially Equivalent |
| K820491 | SGPT REAGENT SET | Mar 11, 1982 | Substantially Equivalent |
| K820500 | TOTAL LIPID REAGENT SET | Mar 11, 1982 | Substantially Equivalent |
| K820466 | SGOT REAGENT SET | Mar 11, 1982 | Substantially Equivalent |
| K812837 | ALKALINE PHOSPHATASE REAGENT SET | Jan 29, 1982 | Substantially Equivalent |