FDA.reportPublic FDA data

510(k) K820796

Device
#4001 Tubed Media - Fluid Thioglycollate
Applicant
BIOMEDICA, INC.
510(k) number
K820796
Product code
JSC
Decision
Substantially Equivalent (SESE)
Decision date
1982-04-08
Date received
1982-03-23
Regulation
866.2350
Classification name
Culture Media, General Nutrient Broth
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JSC#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K850143SPORDEX CULTURE MEDIAAmerican Sterilizer Co.1985-03-05
K842852BRAIN HEART INFUSION BROTHAnarobe Systems1984-08-03
K842849TRYPTICASE SOY BROTHAnarobe Systems1984-08-03
K841221BRAIN HEART INFUSION BROTHAnaerobe Systems1984-04-04
K841219SHOPPED MEAT CARBOHYDRATEAnaerobe Systems1984-04-04
K833300SABOURAUD BHI AGARAcumedia Manufacturers, Inc.1983-11-07
K832620TRYPTIC SOY BROTH MEDIACarroll Biological Corp.1983-09-12
K832619THIOGLYCOLLATE MEDIUMCarroll Biological Corp.1983-09-12
K832570EXTRACT BROTHAcumedia Manufacturers, Inc.1983-09-12
K832569INFUSION BROTHAcumedia Manufacturers, Inc.1983-09-12
K830437CHSDms Laboratories1983-03-17
K822487MINITEK GRAM-POSITIVE BROTH & SET ANDBd Becton Dickinson Vacutainer Systems Preanalytic1982-09-21
K822665WILKINS-CHALGREN ANAEROBE BROTHOxoid U.S.A., Inc.1982-09-21
K821864THIOGLYCOLLATE MED. W/VITAMIN K-1Granite Diagnostics, Inc.1982-07-13
K821597BRAIN HEART INFUSIONHardy Media1982-07-08