CD-CHEX + RBC

Control, White-cell

STRECK LABORATORIES, INC.

The following data is part of a premarket notification filed by Streck Laboratories, Inc. with the FDA for Cd-chex + Rbc.

Pre-market Notification Details

Device IDK960894
510k NumberK960894
Device Name:CD-CHEX + RBC
ClassificationControl, White-cell
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 CodeGGL  
CFR Regulation Number864.8625 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-03-05
Decision Date1996-05-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00844509000174 K960894 000
20844509000093 K960894 000
20844509000130 K960894 000
20844509000147 K960894 000
30844509000083 K960894 000
30844509000090 K960894 000
30844509000137 K960894 000
30844509000144 K960894 000
40844509000080 K960894 000
40844509000134 K960894 000
40844509000141 K960894 000
00844509000105 K960894 000
00844509000112 K960894 000
00844509000129 K960894 000
00844509000150 K960894 000
00844509000167 K960894 000
20844509000086 K960894 000

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