FDA.reportPublic FDA data

510(k) K070691

Device
BBL CHROMAGAR 0157
Applicant
BECTON, DICKINSON & CO.
510(k) number
K070691
Product code
JSI  
Decision
Substantially Equivalent (SESE)
Decision date
2007-11-20
Date received
2007-03-13
Regulation
866.2360
Classification name
Culture Media, Selective And Differential
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DENNIS R MERTZ
Address
7loveton Cir. Sparks MD US 21152 21152

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JSI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K974428DIPSTREAKNovamed , Ltd.1998-07-30
K891593LISTERIA SELECTIVE ENRICHMENT MEDIUMOxoid U.S.A., Inc.1989-06-09
K890199DENTOCULT SM-STRIP MUTANSOrion Corp.1989-03-02
K882182SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P3326Lakewood Biochemical Co., Inc.1988-06-06
K881577MODIFIED SELECTIVE STREPTOCOCCUS AGARAcumedia Manufacturers, Inc.1988-04-18
K881576SELENITE BROTHAcumedia Manufacturers, Inc.1988-04-18
K881575SELECTIVE STREPTOCOCCUS AGARAcumedia Manufacturers, Inc.1988-04-18
K881572XL AGAR BASEAcumedia Manufacturers, Inc.1988-04-18
K881556TRICHOMONAS BROTHAcumedia Manufacturers, Inc.1988-04-18
K881555TINSDALE AGAR BASEAcumedia Manufacturers, Inc.1988-04-18
K880125LOWENSTEIN-JENSEN, SELECTIVEHardy Media1988-03-31
K880132DERMATOPHYTE TEST MEDIUMHardy Media1988-03-30
K880130ATS MEDIAHardy Media1988-03-30
K880108CORN MEAL W/POLYSORBATE 80Hardy Media1988-03-30
K873258STREPTOCOCCAL SELECTIVE DIFFEREN. & ENRICHED MEDIACentral Media1987-11-06

Legacy Summary#

summary

FDA Review#

Decision Summary