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510(k) K844544

Device
CYSTINE TRYPTIC AGAR W/MALTOSE
Applicant
BIO MERIEUX, INC.
510(k) number
K844544
Product code
JSF  
Decision
Substantially Equivalent (SESE)
Decision date
1985-01-16
Date received
1984-11-21
Regulation
866.2320
Classification name
Culture Media, Single Biochemical Test
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
MICKI A MAXWELL
Address
421 Irmen Dr. Addison IL US 60101 60101

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JSF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K880946NUTRIENT GELATIN - PRODUCT NUMBER T2860Lakewood Biochemical Co., Inc.1988-04-01
K880126LAURYL TRYPTOSE BROTHHardy Media1988-03-31
K880120MOELLERS DECARBOXYLASE, LYSINEHardy Media1988-03-31
K880119MOELLERS DECARBOXYLASE, ONITHINEHardy Media1988-03-31
K880139ONPG TEST REAGENTHardy Media1988-03-30
K880135NITRATE BROTHHardy Media1988-03-30
K880129BRILLIANT GREEN BILE BROTHHardy Media1988-03-30
K880118MOELLOERS DECARBOXYLASE, ARGININEHardy Media1988-03-30
K880113CYSTINE TRYPTIC MEDIUM W/LACTOSEHardy Media1988-03-30
K880112CYSTINE TRYPTIC MEDIUM W/ MALTOSEHardy Media1988-03-30
K880111CYSTINE TRYPTIC MEDIUM W/SUCROSEHardy Media1988-03-30
K880110CYSTINE TRYPTIC MEDIUM W/DEXTROSEHardy Media1988-03-30
K880106ACETAMIDE AGAR SLANTHardy Media1988-03-30
K880115NUTRIENT GELATINHardy Media1988-03-08
K874175BIOTIS (TM) MUELLER HINTON W/4% SALT, 6MCG/ML OXACOtisville Biopharm, Inc.1987-12-04

Legacy Summary#

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FDA Review#

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