FDA.reportPublic FDA data

510(k) K883075

Device
Fastidious Inoculum Broth
Applicant
BAXTER HEALTHCARE CORP.
510(k) number
K883075
Product code
JSD
Decision
Substantially Equivalent (SESE)
Decision date
1988-08-15
Date received
1988-07-13
Regulation
866.2360
Classification name
Culture Media, Selective Broth
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
WEAVER HUFFMAN
Address
1584 Enterprise Blvd. West Sacramento CA US 95691 95691

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JSD#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K880107CAMPY BROTHHardy Media1988-03-30
K873324SABOURAUD DEXTROSE (SD) BROTH TUBE, #T3331Lakewood Biochemical Co., Inc.1987-10-02
K873218BRAIN HEART INFUSION BROTH W/6.5% NAC1 - #T3802Lakewood Biochemical Co., Inc.1987-09-23
K871640ALKALINE PEPTONE WATERBd Becton Dickinson Vacutainer Systems Preanalytic1987-05-13
K871447TODD HEWITT W/CNA (LIM BROTH)Remel Co.1987-05-13
K870594T9802 TSB W/6.5% NACLLakewood Biochemical Co., Inc.1987-03-30
K853609APL TRYPTIC SOY BROTHApl Medical Supplies1985-09-12
K844547TRYPTIC SOY BROTH W/6.5%SODIUM CHLORIDEbioMerieux, Inc.1985-01-16
K841836SELECTIVE CULTURE MED. TRICHOMONASMicroline Scientific1984-05-14
K840971SELECTIVE CULTURE MEDIUMChatham Biological1984-04-13
K841211SELECTIVE BROTHSmith River Biologicals1984-04-05
K834013SF BROTHMicro Media Laboratories1983-12-27
K834015SELENITE BROTHMicro Media Laboratories1983-12-22
K833759GROUP STREP BROTH T3472 LIMGibco Laboratories Life Technologies, Inc.1983-12-16
K832310ROGOSA BROTHOxoid U.S.A., Inc.1983-09-01