ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS— 510(k) K000958
Substantially EquivalentElan Holdings, Inc.
FDA 510(k) clearance K000958 for ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS, Substantially Equivalent on 2000-05-24. Applicant: Elan Holdings, Inc..
Clearance details
- Applicant
- Elan Holdings, Inc.
- Product code
- Code CDQ
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brea, CA, US
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