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510(k) K900484

Device
RET-CHECK
Applicant
STRECK LABORATORIES, INC.
510(k) number
K900484
Product code
GJR  
Decision
Substantially Equivalent (SESE)
Decision date
1990-03-09
Date received
1990-02-01
Regulation
864.8625
Classification name
Control, Red-cell
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
HALVOR SORNSON
Address
14306 Industrial Rd. P.O. Box 37625 Omaha NE US 68144 68144

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K000076CELL-CHEXStreck Laboratories, Inc.2000-03-03
K940430SEDRATROLMedical Specialties Intl., Inc.1995-02-06

Legacy Summary#

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FDA Review#

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