SCS-1000 (SYSMEX CALIBRATOR SYSTEM)

Calibrator For Red-cell And White-cell Counting

STRECK LABORATORIES, INC.

The following data is part of a premarket notification filed by Streck Laboratories, Inc. with the FDA for Scs-1000 (sysmex Calibrator System).

Pre-market Notification Details

Device IDK943268
510k NumberK943268
Device Name:SCS-1000 (SYSMEX CALIBRATOR SYSTEM)
ClassificationCalibrator For Red-cell And White-cell Counting
Applicant STRECK LABORATORIES, INC. 14306 INDUSTRIAL RD. P.O. BOX 37625 Omaha,  NE  68144
ContactTheodore W Heise
CorrespondentTheodore W Heise
STRECK LABORATORIES, INC. 14306 INDUSTRIAL RD. P.O. BOX 37625 Omaha,  NE  68144
Product CodeKSA  
CFR Regulation Number864.8185 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-07-07
Decision Date1994-12-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
14987562460370 K943268 000

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