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510(k) K872834

Device
TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410
Applicant
HELENA LABORATORIES
510(k) number
K872834
Product code
CZJ  
Decision
Substantially Equivalent (SESE)
Decision date
1987-08-12
Date received
1987-07-17
Regulation
866.5510
Classification name
Igd, Antigen, Antiserum, Control
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
PAT FRANKS
Address
1530 Lindbergh Dr. P.O. Box 752 Beaumont TX US 77704 77704

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CZJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K092450HUMAN IGD KIT FOR USE ON SPAPLUSThe Binding Site2009-12-28
K051299IGD DIAGNOSTIC TEST KITSThe Binding Site, Ltd.2005-11-23
K002561SHEEP ANTI-HUMAN IGD IMMUNOFIXATION GRADE KITThe Binding Site, Ltd.2000-10-26
K913671HUMAN IGD IMMUNOLOGICAL NL TEST KITThe Binding Site, Ltd.1991-12-02
K883001QM300 CALIBRATOR D PACKKallestad Diag, A Div. of Erbamont, Inc.1988-09-22
K831956DETERM. SIZE 72 RADIAL-HUMAN IGDKent Laboratories, Inc.1983-07-18
K772327LAS-R HUMAN IGD TESTHyland Therapeutic Div., Travenol Laboratories1978-02-28

Legacy Summary#

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FDA Review#

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