CALCIUM PROCEDURE, TEKPOINT DIRECT— 510(k) K770449
Substantially EquivalentIcn Pharmaceuticals, Inc.
FDA 510(k) clearance K770449 for CALCIUM PROCEDURE, TEKPOINT DIRECT, Substantially Equivalent on 1977-05-03. Applicant: Icn Pharmaceuticals, Inc.. Device class: 2.
Clearance details
- Applicant
- Icn Pharmaceuticals, Inc.
- Product code
- Code CIC
- Device class
- Class 2
- Regulation
- 21 CFR 862.1145
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Orangeburg, NY, US
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