IL TEST APTT-SP

Activated Partial Thromboplastin

INSTRUMENTATION LABORATORY CO.

The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Il Test Aptt-sp.

Pre-market Notification Details

Device IDK973306
510k NumberK973306
Device Name:IL TEST APTT-SP
ClassificationActivated Partial Thromboplastin
Applicant INSTRUMENTATION LABORATORY CO. 526 RT. 303 Orangeburg,  NY  10962
ContactCarol Marble
CorrespondentCarol Marble
INSTRUMENTATION LABORATORY CO. 526 RT. 303 Orangeburg,  NY  10962
Product CodeGFO  
CFR Regulation Number864.7925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-09-03
Decision Date1997-11-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08426950078937 K973306 000
08426950023487 K973306 000

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