ACS ULTRA-1 THROMBOPLASTIN

Test, Time, Prothrombin

ANALYTICAL CONTROL SYSTEMS, INC.

The following data is part of a premarket notification filed by Analytical Control Systems, Inc. with the FDA for Acs Ultra-1 Thromboplastin.

Pre-market Notification Details

Device IDK913249
510k NumberK913249
Device Name:ACS ULTRA-1 THROMBOPLASTIN
ClassificationTest, Time, Prothrombin
Applicant ANALYTICAL CONTROL SYSTEMS, INC. 9058 TECHNOLOGY DR. Fishers,  IN  46038
ContactPauline Bonderman
CorrespondentPauline Bonderman
ANALYTICAL CONTROL SYSTEMS, INC. 9058 TECHNOLOGY DR. Fishers,  IN  46038
Product CodeGJS  
CFR Regulation Number864.7750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-07-22
Decision Date1991-12-04

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