TRACE REAGENT LINE FOR THE COBAS MIRA— 510(k) K973869
Substantially EquivalentTrace America, Inc.
FDA 510(k) clearance K973869 for TRACE REAGENT LINE FOR THE COBAS MIRA, Substantially Equivalent on 1998-01-07. Applicant: Trace America, Inc.. Device class: 1.
Clearance details
- Applicant
- Trace America, Inc.
- Product code
- Code CKA
- Device class
- Class 1
- Regulation
- 21 CFR 862.1030
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami, FL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.