UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)— 510(k) K971477
Substantially EquivalentTrace America, Inc.
FDA 510(k) clearance K971477 for UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST), Substantially Equivalent on 1997-05-27. Applicant: Trace America, Inc.. Device class: 2.
Clearance details
- Applicant
- Trace America, Inc.
- Product code
- Code CDQ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1770
- 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.