ATAC PAK AST REAGENT KIT— 510(k) K010488
Substantially EquivalentElan Holdings, Inc.
FDA 510(k) clearance K010488 for ATAC PAK AST REAGENT KIT, Substantially Equivalent on 2001-04-09. Applicant: Elan Holdings, Inc.. Device class: 2.
Clearance details
- Applicant
- Elan Holdings, Inc.
- Product code
- Code CIT
- Device class
- Class 2
- Regulation
- 21 CFR 862.1100
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brea, CA, US
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