ELECTRA(R) 800 AUTOMATIC COAGULATION TIMER

System, Multipurpose For In Vitro Coagulation Studies

MEDICAL LABORATORY AUTOMATION SYSTEMS, INC.

The following data is part of a premarket notification filed by Medical Laboratory Automation Systems, Inc. with the FDA for Electra(r) 800 Automatic Coagulation Timer.

Pre-market Notification Details

Device IDK864534
510k NumberK864534
Device Name:ELECTRA(R) 800 AUTOMATIC COAGULATION TIMER
ClassificationSystem, Multipurpose For In Vitro Coagulation Studies
Applicant MEDICAL LABORATORY AUTOMATION SYSTEMS, INC. 270 MARBLE AVE. Pleasantville,  NY  10570
ContactJohn V Belliotti
CorrespondentJohn V Belliotti
MEDICAL LABORATORY AUTOMATION SYSTEMS, INC. 270 MARBLE AVE. Pleasantville,  NY  10570
Product CodeJPA  
CFR Regulation Number864.5425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-11-17
Decision Date1987-02-06

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