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510(k) K940557

Device
STAPHYTECT-OD
Applicant
UNIPATH LTD.
510(k) number
K940557
Product code
LHJ  
Decision
Substantially Equivalent (SESE)
Decision date
1994-07-28
Date received
1994-02-07
Regulation
866.3700
Classification name
Staphylococcus Aureus Protein A Insoluble
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
Louise Roberts
Address
Norse Rd. Bedford Mk41 Oqg GB

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LHJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K842709IMMUSTAPH LATEX AGGLUTINATION KITImmucell Corp.1984-08-03
K812181STAPHYLOCOCCAL PROTEIN A INSOLUBLEOxoid U.S.A., Inc.1981-08-25

Legacy Summary#

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FDA Review#

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