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510(k) K000076

Device
CELL-CHEX
Applicant
STRECK LABORATORIES, INC.
510(k) number
K000076
Product code
GJR  
Decision
Substantially Equivalent (SESE)
Decision date
2000-03-03
Date received
2000-01-10
Regulation
864.8625
Classification name
Control, Red-cell
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
PAUL KITTELSON
Address
14124 Industrial Rd. Omaha NE US 68145 68145

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GJR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K080016NRBC-CHEX FOR ADVIAStreck2008-02-05
K060083NRBC-CHEX FOR LHStreck2006-02-09
K940430SEDRATROLMedical Specialties Intl., Inc.1995-02-06
K900484RET-CHECKStreck Laboratories, Inc.1990-03-09

Legacy Summary#

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FDA Review#

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