U.S. DIAGNOSTIC INC. HEMOGLOBIN TEST (DRY PACK)— 510(k) K862641

Name: FDA 510(k) clearance K862641
Creator: U.S. Food and Drug Administration
Published: 1986-08-21

Substantially Equivalent

U. S. Diagnostics, Inc.

FDA 510(k) clearance K862641 for U.S. DIAGNOSTIC INC. HEMOGLOBIN TEST (DRY PACK), Substantially Equivalent on 1986-08-21. Applicant: U. S. Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: U. S. Diagnostics, Inc.
Product code: Code KHG
Device class: Class 2
Regulation: 21 CFR 864.7500
Advisory panel: Hematology
Date received: 1986-07-11
Decision date: 1986-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Luis Obispo, CA, US

Download summary PDF View on FDA.gov ↗

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