SELF ASSURE/GHB (CAPILLARY-BLOOD COLLECTION KIT)— 510(k) K861697

Name: FDA 510(k) clearance K861697
Creator: U.S. Food and Drug Administration
Published: 1986-08-19

Substantially Equivalent

Awareness Technology, Inc.

FDA 510(k) clearance K861697 for SELF ASSURE/GHB (CAPILLARY-BLOOD COLLECTION KIT), Substantially Equivalent on 1986-08-19. Applicant: Awareness Technology, Inc.. Device class: 2.

Clearance details

Applicant: Awareness Technology, Inc.
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 1986-05-05
Decision date: 1986-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm City, FL, US

Download summary PDF View on FDA.gov ↗

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