FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ENZYMATIC CHOLESTEROL KIT
K Number: K820951
·
Decision Apr 26, 1982
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
229
Applicant Total
26
Review Days
20
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Basic Information
- Device Name
- ENZYMATIC CHOLESTEROL KIT
- K Number
- K820951
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1175
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Anco Medical Reagents & Assoc.
- Date Received
- April 6, 1982
- Decision Date
- April 26, 1982
- Product Code
- CHH
- 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 |
|---|---|---|---|
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | FDA class 1 | Clinical Chemistry |
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Other Clearances by Anco Medical Reagents & Assoc.
| K Number | Device Name | ||
|---|---|---|---|
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| 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 |
| 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 |
| K813415 | UREA NITROGEN REAGENT SET | Dec 31, 1981 | Substantially Equivalent |