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510(k) K881064

Device
HYGEIA GC TEST
Applicant
HYGEIA SCIENCES
510(k) number
K881064
Product code
LIR  
Decision
Substantially Equivalent (SESE)
Decision date
1988-06-02
Date received
1988-03-14
Regulation
866.3390
Classification name
Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
CANNON, PHD
Address
330 Nevada St. Newton MA US 02160 02160

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LIR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K023947GC OIAThermo Biostar, Inc.2003-04-17
K882534ABBOTT TESTPACK(TM) GONORRHEA POSITIVE CONTROLAbbott Laboratories1988-07-12

Legacy Summary#

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FDA Review#

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