ELECSYS CALCHECK TROPONIN T— 510(k) K984372
Substantially EquivalentBoehringer Mannheim Corp.
FDA 510(k) clearance K984372 for ELECSYS CALCHECK TROPONIN T, Substantially Equivalent on 1998-12-14. Applicant: Boehringer Mannheim Corp.. Device class: 1.
Clearance details
- Applicant
- Boehringer Mannheim Corp.
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
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