FDA.reportPublic FDA data

510(k) K864078

Device
Modified N.y.c. Fermentation Medium Base
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
510(k) number
K864078
Product code
JTY
Decision
Substantially Equivalent (SESE)
Decision date
1986-10-31
Date received
1986-10-20
Regulation
866.2410
Classification name
Culture Media, For Isolation Of Pathogenic Neisseria
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
RUSSELL ARNSBERGER
Address
1 Becton Dr. Franklin Lakes NJ US 07417 07417

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JTY#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K210511InTray GCBiomed Diagnostics Incorporated2021-10-20
K993033INTRAY GCBiomed Diagnostics, Inc.1999-12-16
K954986GC BASE W/ 1% GCHIRemel, L.P.1996-02-16
K950196CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIABioclinical Systems, Inc.1995-06-30
K933122MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGARBioclinical Systems, Inc.1994-02-09
K933121MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGARBioclinical Systems, Inc.1994-02-03
K934331THAYER MARTIN, MODIFIED PILL POCKETHardy Diagnostics1993-12-21
K934330TRANSGROWHardy Diagnostics1993-12-17
K931864MARTIN LEWIS WITH LINOCMYCINHardy Diagnostics1993-12-15
K881552PROTEOSE NO. 3 AGARAcumedia Manufacturers, Inc.1988-04-18
K881527CASMAN MEDIUM BASEAcumedia Manufacturers, Inc.1988-04-18
K871541MARTIN-LEWIS AGAR W/REDUCED VANCOMYCIN C0226Gibco Laboratories Life Technologies, Inc.1987-04-29
K864253THAYER MARTIN AGARMds Laboratories, Inc.1987-03-31
K864252THAYER-MARTIN JEMBECMds Laboratories, Inc.1987-03-31
K864803GC-LECT(TM)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-02-03