PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS

Counter, Cell, Automated (particle Counter)

DIAGNOSTIC TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Diagnostic Technology, Inc. with the FDA for Pha-2 Conversion Program For Platelet Analysis.

Pre-market Notification Details

Device IDK860586
510k NumberK860586
Device Name:PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS
ClassificationCounter, Cell, Automated (particle Counter)
Applicant DIAGNOSTIC TECHNOLOGY, INC. 240 VANDERBILT MOTOR PKWY. Hauppauge,  NY  11788
ContactRobert E Lind
CorrespondentRobert E Lind
DIAGNOSTIC TECHNOLOGY, INC. 240 VANDERBILT MOTOR PKWY. Hauppauge,  NY  11788
Product CodeGKL  
CFR Regulation Number864.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-02-19
Decision Date1986-05-07

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