ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33560, 33565— 510(k) K001935
Substantially EquivalentBeckman Coulter, Inc.
FDA 510(k) clearance K001935 for ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33560, 33565, Substantially Equivalent on 2000-08-22. Applicant: Beckman Coulter, Inc.. Device class: 1.
Clearance details
- Applicant
- Beckman Coulter, Inc.
- Product code
- Code CDZ
- Device class
- Class 1
- Regulation
- 21 CFR 862.1680
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chaska, MN, US
Recent devices under product code CDZ
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