ELECTRA 1600C AUTOMATIC COAGULATION TIMER— 510(k) K931206

Name: FDA 510(k) clearance K931206
Creator: U.S. Food and Drug Administration
Published: 1993-08-23

Substantially Equivalent

Medical Laboratory Automation Systems, Inc.

FDA 510(k) clearance K931206 for ELECTRA 1600C AUTOMATIC COAGULATION TIMER, Substantially Equivalent on 1993-08-23. Applicant: Medical Laboratory Automation Systems, Inc.. Device class: 2.

Clearance details

Applicant: Medical Laboratory Automation Systems, Inc.
Product code: Code GKP
Device class: Class 2
Regulation: 21 CFR 864.5400
Advisory panel: Hematology
Date received: 1993-03-10
Decision date: 1993-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasantville, NY, US

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