SPOTTEST CALCOFLUOR WHITE REAGENT— 510(k) K860795

Name: FDA 510(k) clearance K860795
Creator: U.S. Food and Drug Administration
Published: 1986-03-12

Substantially Equivalent

Difco Laboratories, Inc.

FDA 510(k) clearance K860795 for SPOTTEST CALCOFLUOR WHITE REAGENT, Substantially Equivalent on 1986-03-12. Applicant: Difco Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Difco Laboratories, Inc.
Product code: Code LED
Device class: Class 1
Regulation: 21 CFR 864.1850
Advisory panel: Hematology
Date received: 1986-03-04
Decision date: 1986-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Detroit, MI, US

Download summary PDF View on FDA.gov ↗

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