KING DIAGNOSTICS UREA NITROGEN REAGENT— 510(k) K922969
Substantially EquivalentKing Diagnostics, Inc.
FDA 510(k) clearance K922969 for KING DIAGNOSTICS UREA NITROGEN REAGENT, Substantially Equivalent on 1992-10-13. Applicant: King Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- King Diagnostics, Inc.
- Product code
- Code CDN
- Device class
- Class 2
- Regulation
- 21 CFR 862.1770
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
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