FDA.reportPublic FDA data

510(k) K944847

Device
KULTSURE/STARSWAB ANAEROBIC TRANSPORT SYSTEM
Applicant
STARPLEX SCIENTIFIC, INC.
510(k) number
K944847
Product code
JSL  
Decision
Substantially Equivalent (SESE)
Decision date
1995-02-16
Date received
1994-09-30
Regulation
866.2390
Classification name
Culture Media, Anaerobic Transport
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
MEHDI KARAMCHI
Address
50 Steinway Blvd. Unit #5 Etobicoke, Ontario CA M9W 6Y3 M9W 6Y3

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JSL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K972448COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOALCopan Italia Spa1997-08-20
K972449COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOALCopan Italia Spa1997-08-20
K925450BIONOR TRANSPORTMEDIUMSkoug Research Corp.1993-06-25
K841220ANAEROBIC TRANSPORT MEDIUMAnaerobe Systems1984-04-04
K834357ANA TRANS TUBE & SWABS STERILE PACKAnaerobe Systems1984-01-31
K770840PRE-REDUCED ANAEROBIC MEDIAGibco Laboratories Life Technologies, Inc.1977-06-08
K770650PRE-DUCED CULTURE MEDIAGibco Laboratories Life Technologies, Inc.1977-04-15

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases