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510(k) K834357

Device
ANA TRANS TUBE & SWABS STERILE PACK
Applicant
ANAEROBE SYSTEMS
510(k) number
K834357
Product code
JSL  
Decision
Substantially Equivalent (SESE)
Decision date
1984-01-31
Date received
1983-12-13
Regulation
866.2390
Classification name
Culture Media, Anaerobic Transport
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

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
K925450BIONOR TRANSPORTMEDIUMSkoug Research Corp.1993-06-25
K841220ANAEROBIC TRANSPORT MEDIUMAnaerobe Systems1984-04-04
K770840PRE-REDUCED ANAEROBIC MEDIAGibco Laboratories Life Technologies, Inc.1977-06-08
K770650PRE-DUCED CULTURE MEDIAGibco Laboratories Life Technologies, Inc.1977-04-15

Legacy Summary#

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FDA Review#

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