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510(k) K940430

Device
SEDRATROL
Applicant
MEDICAL SPECIALTIES INTL., INC.
510(k) number
K940430
Product code
GJR  
Decision
Substantially Equivalent (SESE)
Decision date
1995-02-06
Date received
1994-01-31
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
W. KEVIN LIDDLE
Address
3610 Kennedy Rd. South Plainfield NJ US 07080 07080

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
K000076CELL-CHEXStreck Laboratories, Inc.2000-03-03
K900484RET-CHECKStreck Laboratories, Inc.1990-03-09

Legacy Summary#

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FDA Review#

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