ACCESS DHEA-S REAGENT ASSAY— 510(k) K040181
Substantially EquivalentBeckman Coulter, Inc.
FDA 510(k) clearance K040181 for ACCESS DHEA-S REAGENT ASSAY, Substantially Equivalent on 2004-03-24. Applicant: Beckman Coulter, Inc.. Device class: 1.
Clearance details
- Applicant
- Beckman Coulter, Inc.
- Product code
- Code JKC
- Device class
- Class 1
- Regulation
- 21 CFR 862.1245
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Brea, CA, US
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