THROMBIN CLOT TIME TEST PROCEDURE— 510(k) K923220

Name: FDA 510(k) clearance K923220
Creator: U.S. Food and Drug Administration
Published: 1992-09-29

Substantially Equivalent

Medical Laboratory Automation Systems, Inc.

FDA 510(k) clearance K923220 for THROMBIN CLOT TIME TEST PROCEDURE, Substantially Equivalent on 1992-09-29. Applicant: Medical Laboratory Automation Systems, Inc.. Device class: 2.

Clearance details

Applicant: Medical Laboratory Automation Systems, Inc.
Product code: Code GJA
Device class: Class 2
Regulation: 21 CFR 864.7875
Advisory panel: Hematology
Date received: 1992-07-01
Decision date: 1992-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasantville, NY, US

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