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510(k) K850720

Device
Eosin Methylene Blue Agar, Ss Agar, Xld Agar 6.5%
Applicant
RAPID CITY REGIONAL HOSPITAL, INC.
510(k) number
K850720
Product code
JSI
Decision
Substantially Equivalent (SESE)
Decision date
1985-03-22
Date received
1985-02-22
Regulation
866.2360
Classification name
Culture Media, Selective And Differential
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
SHEILA M HILLBERRY
Address
353 Fairmont Blvd. Rapid City SD US 57701 57701

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JSI#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K070691BBL CHROMAGAR 0157Becton, Dickinson & CO2007-11-20
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
K881555TINSDALE AGAR BASEAcumedia Manufacturers, Inc.1988-04-18
K881556TRICHOMONAS BROTHAcumedia Manufacturers, Inc.1988-04-18
K881572XL AGAR BASEAcumedia Manufacturers, Inc.1988-04-18
K881575SELECTIVE STREPTOCOCCUS AGARAcumedia Manufacturers, Inc.1988-04-18
K881576SELENITE BROTHAcumedia Manufacturers, Inc.1988-04-18
K881577MODIFIED SELECTIVE STREPTOCOCCUS AGARAcumedia Manufacturers, Inc.1988-04-18
K880125LOWENSTEIN-JENSEN, SELECTIVEHardy Media1988-03-31
K880108CORN MEAL W/POLYSORBATE 80Hardy Media1988-03-30
K880130ATS MEDIAHardy Media1988-03-30
K880132DERMATOPHYTE TEST MEDIUMHardy Media1988-03-30