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510(k) K871092

Device
Horse Blood Agar, Enriched
Applicant
BIO MERIEUX, INC.
510(k) number
K871092
Product code
KZI
Decision
Substantially Equivalent (SESE)
Decision date
1987-04-03
Date received
1987-03-18
Regulation
866.2330
Classification name
Culture Media, Enriched
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 KZI#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K884208LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION)Oxoid U.S.A., Inc.1988-10-25
K881995DIAMOND'S MEDIUM MODIFIEDRemel Co.1988-06-02
K880134MIDDLEBROOK 7H11 AGARHardy Media1988-03-31
K880131LOWENSTEIN-JENSEN, GRUFTHardy Media1988-03-31
K880122MIDDLEBROOK 7H9 BROTHHardy Media1988-03-31
K880138WALLENSTEIN MEDIUM SLANTHardy Media1988-03-30
K880109CYSTINE TRYPTIC MEDIUM BASEHardy Media1988-03-30
K880127POTATO DEXTROSE AGARHardy Media1988-03-07
K874179BIOTIS (TM) SABHI (DOUBLE POUR)Otisville Biopharm, Inc.1988-01-28
K874177BIOTIS (TM) BCYEOtisville Biopharm, Inc.1987-12-04
K873267ECG BASED MEDIACentral Media1987-11-04
K873266MIDDLEBROOK BASED MEDIACentral Media1987-10-28
K873952MICRO CULTURE MEDIA P3141, P3136, P3148, P3748Lakewood Biochemical Co., Inc.1987-10-23
K873321SABOUR DEXTROSE/BHI SD/BHI AGAR SLT TUBE #T4300Lakewood Biochemical Co., Inc.1987-09-29
K873320SABOURAUD DEXTR/BHI SD/BHI AGAR SLT W/6% SHEEP BLDLakewood Biochemical Co., Inc.1987-09-29