SPOTTEST IODINE SOLUTION DOBELL & O'CONNOR— 510(k) K851481

Name: FDA 510(k) clearance K851481
Creator: U.S. Food and Drug Administration
Published: 1985-04-29

Substantially Equivalent

Difco Laboratories, Inc.

FDA 510(k) clearance K851481 for SPOTTEST IODINE SOLUTION DOBELL & O'CONNOR, Substantially Equivalent on 1985-04-29. 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: 1985-04-15
Decision date: 1985-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Detroit, MI, US

Download summary PDF View on FDA.gov ↗

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