FREE T3 CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS— 510(k) K042651
Substantially EquivalentBeckman Coulter, Inc.
FDA 510(k) clearance K042651 for FREE T3 CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, Substantially Equivalent on 2004-10-05. Applicant: Beckman Coulter, Inc.. Device class: 2.
Clearance details
- Applicant
- Beckman Coulter, Inc.
- Product code
- Code JIT
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chaska, MN, US
Recent devices under product code JIT
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