DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)— 510(k) K032697
Substantially EquivalentDade Behring, Inc.
FDA 510(k) clearance K032697 for DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414), Substantially Equivalent on 2003-11-07. Applicant: Dade Behring, Inc.. Device class: 2.
Clearance details
- Applicant
- Dade Behring, Inc.
- Product code
- Code JIS
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newark, DE, US
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