FDA.reportPublic FDA data

510(k) K925450

Device
BIONOR TRANSPORTMEDIUM
Applicant
SKOUG RESEARCH CORP.
510(k) number
K925450
Product code
JSL  
Decision
Substantially Equivalent (SESE)
Decision date
1993-06-25
Date received
1992-10-28
Regulation
866.2390
Classification name
Culture Media, Anaerobic Transport
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
ERIK SKOUG
Address
P.O. Box 405 Cambridge MA US 02141 02141

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K944847KULTSURE/STARSWAB ANAEROBIC TRANSPORT SYSTEMStarplex Scientific, Inc.1995-02-16
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