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510(k) K892424

Device
Rep Spe Hi-res System No. 3176, 3177, 3178
Applicant
HELENA LABORATORIES
510(k) number
K892424
Product code
CFF
Decision
Substantially Equivalent (SESE)
Decision date
1989-06-09
Date received
1989-04-10
Regulation
866.5510
Classification name
Immunoelectrophoretic, Immunoglobulins, (G, A, M)
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

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K033277HYDRAGEL CSF ISOFOCUSING KITSMorax2003-11-04
K024162SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389Helena Laboratories2003-02-19