FDA.reportPublic FDA data

510(k) K872301

Device
DENTOCULT-SM CULTURE-PADDLE
Applicant
ORION CORP.
510(k) number
K872301
Product code
JSI  
Decision
Substantially Equivalent (SESE)
Decision date
1987-09-11
Date received
1987-06-15
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
TIMO RAINES
Address
P.O. Box 425 20101 Turku FI

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
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

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases