STRECK LLC

Registration Details

Registration Name: STRECK LLC
Registration Number: 1950302
FEI Number: 1950302
Status: Active
Expiry Year: 2026
Initial Importer: Yes
Address: 7002 SOUTH 109TH ST.
City: La Vista
State: NE
ZIP: 68128
Country: US

Regulatory Submissions

510(k) Number: K101335

Owner / Operator

Firm Name: STRECK
Operator Number: 1950302
Address: 7002 SOUTH 109TH ST., --
City: La Vista
State: NE
Postal Code: 68128
Country: US
Correspondent: Wendy - Royalty

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Mixture, Control, White-Cell And Red-Cell Indices	GLQ	Class 2	Hematology	No	2013-09-03
Calibrator For Cell Indices	KRX	Class 2	Hematology	No	2014-12-23
Mixture, Hematology Quality Control	JPK	Class 2	Hematology	No	2014-12-23
Material, Quality Control, Semen Analysis	NRF	Class 2	Hematology	No	2015-08-19
Test, Erythrocyte Sedimentation Rate	JPH	Class 1	Hematology	No	1997-05-28
Counter, Differential Cell	GKZ	Class 2	Hematology	No	2013-01-30
Counter, Cell, Automated (Particle Counter)	GKL	Class 2	Hematology	No	2013-01-30
Control, White-Cell	GGL	Class 2	Hematology	No	2007-10-31
Control, Platelet	GJP	Class 2	Hematology	No	2021-11-30
Control, Cell Counter, Normal And Abnormal	JCN	Class 2	Hematology	No	2010-04-05
Calibrator For Red-Cell And White-Cell Counting	KSA	Class 2	Hematology	No	2009-02-02
Calibrator For Hemoglobin And Hematocrit Measurement	KRZ	Class 2	Hematology	No	2007-10-31
Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays	PMN	Class 2	Microbiology	No	2022-01-25
Device, Automated Sedimentation Rate	GKB	Class 1	Hematology	No	2003-08-13
Test, Sickle Cell	GHM	Class 2	Hematology	No	2007-10-31
Tubes, Vacuum Sample, With Anticoagulant	GIM	Class 2	Clinical Chemistry	No	2013-01-21
Blood Collection Device For Cell-Free Nucleic Acid	QMA	Class 2	Clinical Chemistry	No	2020-08-07
Calibrator For Platelet Counting	KRY	Class 2	Hematology	No	2007-10-31
Preservative, Cytological	LEA	Class 1	Pathology	No	2015-06-18

Proprietary Names

Cell-Chex CELL-DYN 29 Plus Control (w/Retics) Alinity h-series HemCal XN CAL XN CHECK BF Sperm-Chex Post VC Sperm-Chex TESTpoint Retic High Control (4 x 4 mL) TESTpoint Retic Low Control (4 x 4 mL) Sysmex e-CHECK XE XN-L CHECK CELL-DYN Retic Plus Control ESR-CHEX PLUS ESR-CHEX CSF Reagent (1 x 8 mL) CD-Chex CD34 CD-Chex Plus CD-Chex Plus CD4 Low Para 12 Extend Platelet CHECK WRP CHECK WRP CHECK EX 3-in-1 TESTpoint Hematology Abnormal Control 2 (4 x 4 mL) 3-in-1 TESTpoint Hematology Abnormal Control 1 (4 x 4 mL) 3-in-1 TESTpoint Hematology Normal Control (4 x 4 mL) Sysmex SCS-1000 Hematology Calibrator TESTpoint Hematology Low Control (4 x 4 mL) TESTpoint Hematology Normal Control (4 x 4 mL) TESTpoint Hematology High Control (4 x 4 mL) X-Cal XN CAL PF ClealLab Control Cells Advia SETpoint Hematology Calibrator (2 x 6.1 mL) STaK-Chex Plus Retics CELL-DYN 18 Plus Control Retic-Chex Linearity for BC CELL-DYN 22 Plus Calibrator CELL-DYN 18 Plus Calibrator CELL-DYN 22 Plus Control MDx-Chex for BCID2 EIGHTCHECK-3WP EIGHTCHECK-3WP X-TRA TESTpoint CSF Controls (2 x 3 mL) MDx-Chex for BC-GN XN CHECK XW QC CHECK Diesse MINI-CUBE Diesse CUBE 30 Touch Para 12 Plus CELL-DYN 26 Plus Control SICKLEDEX Beckman Coulter iQ Body FLuids Cyto-Chex BCT Sickle-Chex Sysmex e-CHECK Sysmex e-CHECK XS Cell-Free DNA BCT MDx-Chex for BC-GP CELL-DYN HemCal Plus Streck Cell Preservative

Establishment Types

Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Complaint File Establishment per 21 CFR 820.198