TECHNICON H* 3TM RTC SYSTEM (IN-VITRO DIAG.SYST.)

Counter, Cell, Automated (particle Counter)

HERAEUS KULZER, INC.

The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Technicon H* 3tm Rtc System (in-vitro Diag.syst.).

Pre-market Notification Details

Device IDK930685
510k NumberK930685
Device Name:TECHNICON H* 3TM RTC SYSTEM (IN-VITRO DIAG.SYST.)
ClassificationCounter, Cell, Automated (particle Counter)
Applicant HERAEUS KULZER, INC. 511 BENEDICT AVE. Tarrytown,  NY  10591 -5097
ContactGabriel J Muraca
CorrespondentGabriel J Muraca
HERAEUS KULZER, INC. 511 BENEDICT AVE. Tarrytown,  NY  10591 -5097
Product CodeGKL  
CFR Regulation Number864.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-02-10
Decision Date1993-06-22

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