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510(k) K954995

Device
QUIX RAPID CHOLERA STRIP TEST
Applicant
GUARDIAN SCIENTIFIC, CORP.
510(k) number
K954995
Product code
GSQ  
Decision
Substantially Equivalent (SESE)
Decision date
1996-08-15
Date received
1995-10-31
Regulation
866.3930
Classification name
Antiserum, Vibrio Cholerae, All Varieties
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
KATHRYN B POWERS
Address
8990-E Rte. 108 Columbia MD US 21045 21045

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GSQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K932622CHOLERA SMART(TM)New Horizons Diagnostics Co.1995-06-27
K922432CHOLERASCREENNew Horizons Diagnostics Co.1992-12-07

Legacy Summary#

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FDA Review#

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