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510(k) K881242

Device
CELL-DYN RAPID-LYSE AND HEMOGLOBLIN
Applicant
ABBOTT DIAGNOSTICS
510(k) number
K881242
Product code
GJZ  
Decision
Substantially Equivalent (SESE)
Decision date
1988-04-21
Date received
1988-03-16
Regulation
864.7500
Classification name
Cyanomethemoglobin Reagent And Standard Solution
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
RUTH M BECKER
Address
850 Maude Ave. Mountain View CA US 94043 94043

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GJZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K883683HEMOGLOBINTech-Co, Inc.1988-10-06

Legacy Summary#

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FDA Review#

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