QUICKCHECK LYOPHILIZED CHEMISTRY CONTROL CONFORMANCE CHEMISTRY CONTROL C3

Multi-analyte Controls, All Kinds (assayed)

CONSOLIDATED TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Consolidated Technologies, Inc. with the FDA for Quickcheck Lyophilized Chemistry Control Conformance Chemistry Control C3.

Pre-market Notification Details

Device IDK981339
510k NumberK981339
Device Name:QUICKCHECK LYOPHILIZED CHEMISTRY CONTROL CONFORMANCE CHEMISTRY CONTROL C3
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant CONSOLIDATED TECHNOLOGIES, INC. 2170 WOODWARD STREET, STE. 100 Austin,  TX  78744 -1832
ContactWilliam Cone
CorrespondentWilliam Cone
CONSOLIDATED TECHNOLOGIES, INC. 2170 WOODWARD STREET, STE. 100 Austin,  TX  78744 -1832
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-04-13
Decision Date1998-04-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817274022368 K981339 000
00817274021163 K981339 000

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