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510(k) K880130

Device
ATS MEDIA
Applicant
HARDY MEDIA
510(k) number
K880130
Product code
JSI  
Decision
Substantially Equivalent (SESE)
Decision date
1988-03-30
Date received
1988-01-06
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
JAY HARDY
Address
205 W.Montecito St. Santa Barbara CA US 93101 93101

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
K880108CORN MEAL W/POLYSORBATE 80Hardy Media1988-03-30
K873258STREPTOCOCCAL SELECTIVE DIFFEREN. & ENRICHED MEDIACentral Media1987-11-06

Legacy Summary#

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FDA Review#

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