CELL-CHEX

Mixture, Control, White-cell And Red-cell Indices

Streck

The following data is part of a premarket notification filed by Streck with the FDA for Cell-chex.

Pre-market Notification Details

Device IDK101335
510k NumberK101335
Device Name:CELL-CHEX
ClassificationMixture, Control, White-cell And Red-cell Indices
Applicant Streck 7002 SOUTH 109TH ST. Omaha,  NE  68128
ContactKerrie Oetter
CorrespondentKerrie Oetter
Streck 7002 SOUTH 109TH ST. Omaha,  NE  68128
Product CodeGLQ  
CFR Regulation Number864.8625 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-05-12
Decision Date2010-08-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00844509000303 K101335 000
00844509000297 K101335 000
00844509000280 K101335 000
30844509000267 K101335 000
20844509000277 K101335 000
20844509000260 K101335 000
20844509000253 K101335 000

Trademark Results [CELL-CHEX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CELL-CHEX
CELL-CHEX
85410938 4166939 Live/Registered
Streck, Inc.
2011-08-30
CELL-CHEX
CELL-CHEX
78700736 not registered Dead/Abandoned
Streck Laboratories, Inc.
2005-08-25
CELL-CHEX
CELL-CHEX
77818922 not registered Dead/Abandoned
Streck, Inc.
2009-09-02
CELL-CHEX
CELL-CHEX
73024278 1027707 Dead/Expired
STRECK LABORATORIES, INC.
1974-06-14

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