MedtechSourcebook

STRECK LLC

Contract manufacturer · La Vista, NE

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

FDA registration
1950302 (openFDA record; or search FDA's registration database)
FEI number
1950302
Registered for
FDA registration year 2026
Establishment types
Complaint file establishment; Manufacturer; Contract manufacturer
Owner or operator
STRECK (FDA owner/operator no. 1950302)
Registered address
7002 SOUTH 109TH ST., La Vista, NE 68128
Contract listings
35 device listings, 10 product codes, first listed Oct 31, 2007
Certification
Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product codeDevice (FDA name)ClassCategoryRoleFirst listed
GJPControl, PlateletClass IIHematologyContract manufacturingNov 30, 2021
GKLCounter, Cell, Automated (Particle Counter)Class IIHematologyContract manufacturingJan 30, 2013
GKZCounter, Differential CellClass IIHematologyContract manufacturingJan 30, 2013
GLQMixture, Control, White-Cell And Red-Cell IndicesClass IIHematologyContract manufacturingOct 31, 2007
JCNControl, Cell Counter, Normal And AbnormalClass IIHematologyContract manufacturingOct 31, 2007
JPKMixture, Hematology Quality ControlClass IIHematologyContract manufacturingOct 31, 2007
KRXCalibrator For Cell IndicesClass IIHematologyContract manufacturingOct 31, 2007
KRYCalibrator For Platelet CountingClass IIHematologyContract manufacturingOct 31, 2007
KRZCalibrator For Hemoglobin And Hematocrit MeasurementClass IIHematologyContract manufacturingOct 31, 2007
KSACalibrator For Red-Cell And White-Cell CountingClass IIHematologyContract manufacturingOct 31, 2007

Other contract facilities of STRECK