BUN (ENZYMATIC BERTHELOT) REAGENT SET— 510(k) K860154
Substantially EquivalentSterling Diagnostics, Inc.
FDA 510(k) clearance K860154 for BUN (ENZYMATIC BERTHELOT) REAGENT SET, Substantially Equivalent on 1986-02-06. Applicant: Sterling Diagnostics, Inc..
Clearance details
- Applicant
- Sterling Diagnostics, Inc.
- Product code
- Code CDL
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sterling Heights, MI, US
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