FDA.reportPublic FDA data

510(k) K080016

Device
NRBC-CHEX FOR ADVIA
Applicant
Streck
510(k) number
K080016
Product code
GJR  
Decision
Substantially Equivalent (SESE)
Decision date
2008-02-05
Date received
2008-01-03
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
ERIN JOHNSON
Address
7002 S 109th St. La Vista NE US 68128 68128

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
K060083NRBC-CHEX FOR LHStreck2006-02-09
K000076CELL-CHEXStreck Laboratories, Inc.2000-03-03
K940430SEDRATROLMedical Specialties Intl., Inc.1995-02-06
K900484RET-CHECKStreck Laboratories, Inc.1990-03-09

Legacy Summary#

summary

FDA Review#

Decision Summary