IL SYSTEM 810, ACL AND THE REAGENT SETS

Test, Thrombin Time

INSTRUMENTATION LABORATORY CO.

The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Il System 810, Acl And The Reagent Sets.

Pre-market Notification Details

Device IDK862301
510k NumberK862301
Device Name:IL SYSTEM 810, ACL AND THE REAGENT SETS
ClassificationTest, Thrombin Time
Applicant INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. P.O. BOX 9113 Lexington,  MA  02173
ContactGeorge A Lyna
CorrespondentGeorge A Lyna
INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. P.O. BOX 9113 Lexington,  MA  02173
Product CodeGJA  
CFR Regulation Number864.7875 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-06-17
Decision Date1986-09-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08426950058366 K862301 000
08426950452836 K862301 000

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