ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL II

Control, Plasma, Abnormal

ANALYTICAL CONTROL SYSTEMS, INC.

The following data is part of a premarket notification filed by Analytical Control Systems, Inc. with the FDA for Acs Animal Plasma Coagulation Control Level Ii.

Pre-market Notification Details

Device IDK893971
510k NumberK893971
Device Name:ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL II
ClassificationControl, Plasma, Abnormal
Applicant ANALYTICAL CONTROL SYSTEMS, INC. 9001 TECHNOLOGY DR. SUITE A Fishers,  IN  46060
ContactPauline Bonderman
CorrespondentPauline Bonderman
ANALYTICAL CONTROL SYSTEMS, INC. 9001 TECHNOLOGY DR. SUITE A Fishers,  IN  46060
Product CodeGGC  
CFR Regulation Number864.5425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-06-02
Decision Date1989-07-25

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817869020243 K893971 000

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