CHOLESTEROL PROCEDURE, TEKPOINT TOTAL— 510(k) K770457
Substantially EquivalentIcn Pharmaceuticals, Inc.
FDA 510(k) clearance K770457 for CHOLESTEROL PROCEDURE, TEKPOINT TOTAL, Substantially Equivalent on 1977-05-03. Applicant: Icn Pharmaceuticals, Inc.. Device class: 1.
Clearance details
- Applicant
- Icn Pharmaceuticals, Inc.
- Product code
- Code CGO
- Device class
- Class 1
- Regulation
- 21 CFR 862.1175
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Orangeburg, NY, US
Recent devices under product code CGO
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