FDA.reportPublic FDA data

510(k) K881115

Device
Bactec(r) Nr26 And Bactec(r) Nr 27 Culture Media
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
510(k) number
K881115
Product code
JSG
Decision
Substantially Equivalent (SESE)
Decision date
1988-03-24
Date received
1988-03-15
Regulation
866.2300
Classification name
Culture Media, Non-Selective And Non-Differential
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
J ARNSBERGER
Address
1 Becton Dr. Franklin Lakes NJ US 07417 07417

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JSG#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K882495THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007Lakewood Biochemical Co., Inc.1988-07-01
K881564TRYPTOSE BLOOD AGAR BASE W/YEAST EXTRACTAcumedia Manufacturers, Inc.1988-04-18
K881563TRYPTOSE PHOSPHATE BROTHAcumedia Manufacturers, Inc.1988-04-18
K881562TRYPTOSE BLOOD AGAR BASEAcumedia Manufacturers, Inc.1988-04-18
K881558TRYPTOSE AGARAcumedia Manufacturers, Inc.1988-04-18
K881557TRYPTONEAcumedia Manufacturers, Inc.1988-04-18
K881554SKIM MILK DEHYDRATEDAcumedia Manufacturers, Inc.1988-04-18
K881550OF BASAL MEDIUMAcumedia Manufacturers, Inc.1988-04-18
K881548MPH AGARAcumedia Manufacturers, Inc.1988-04-18
K881546MALT EXTRACT AGARAcumedia Manufacturers, Inc.1988-04-18
K881545MALT EXTRACTAcumedia Manufacturers, Inc.1988-04-18
K881543LETHEEN AGARAcumedia Manufacturers, Inc.1988-04-18
K881542HEART INFUSION AGARAcumedia Manufacturers, Inc.1988-04-18
K881541GELATINAcumedia Manufacturers, Inc.1988-04-18
K881533BLOOD AGAR BASE NO. 2Acumedia Manufacturers, Inc.1988-04-18