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510(k) K934894

Device
CULTURESWAB TRANSPORT SYSTEM
Applicant
DIFCO LABORATORIES, INC.
510(k) number
K934894
Product code
JTW  
Decision
Substantially Equivalent (SESE)
Decision date
1994-02-22
Date received
1993-10-05
Regulation
866.2900
Classification name
System, Transport, Aerobic
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
DAVID W GATES
Address
P. O. Box 331058 Detroit MI US 48232 48232

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JTW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K121039COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEMCopan Flock Technologies2012-05-25
K061301COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEMCopan Diagnostics, Inc.2006-06-23
K022874GEN-PROBE APTIMA COMBO 2 ASSAYGen-Probe, Inc.2002-09-17
K013819URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEMSierra Diagnostic, LLC2002-02-28
K993161COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEMCopan Diagnostics, Inc.1999-11-09
K983244SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM)Trek Diagnostic Systems, Inc.1998-11-30
K961148CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG)Difco Laboratories, Inc.1996-04-26
K904773P AND T MEDIUMGibson Laboratories, Inc.1990-12-04
K895187FDL, INC.'S TRANSPORT SYSTEMFairleigh Dickinson Laboratories, Inc.1989-10-24
K882580MECHANICAL CHANGE IN IN-VITRO MICRO DEVICEPrecision Dynamics Corp.1988-07-08
K872325GONOSTAT FEMALE SPECIMEN COLLECTION & TRANSPORTTechnology Management & Marketing, Inc.1987-08-12
K872326GONOSTAT MALE SPECIMEN COLLECTION & TRANSPORTTechnology Management & Marketing, Inc.1987-08-11
K843359URINE TRANSPORT KITApplied Polytechnology, Inc.1984-09-27
K843341GONO-PAK W/THAYER-MARTIN AGAR/GONO-PAKBd Becton Dickinson Vacutainer Systems Preanalytic1984-09-27
K843173CELL-MATICS VIRAL TRANSPORT PACKDifco Laboratories, Inc.1984-09-06

Legacy Summary#

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FDA Review#

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