COUNTER-CHECK PLUS NORMAL, HIGH ABN.

Mixture, Hematology Quality Control

DIAGNOSTIC TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Diagnostic Technology, Inc. with the FDA for Counter-check Plus Normal, High Abn..

Pre-market Notification Details

Device IDK791772
510k NumberK791772
Device Name:COUNTER-CHECK PLUS NORMAL, HIGH ABN.
ClassificationMixture, Hematology Quality Control
Applicant DIAGNOSTIC TECHNOLOGY, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJPK  
CFR Regulation Number864.8625 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-09-07
Decision Date1979-10-11

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