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510(k) K871097

Device
Chocolate Mueller Hinton Agar
Applicant
BIO MERIEUX, INC.
510(k) number
K871097
Product code
JTZ
Decision
Substantially Equivalent (SESE)
Decision date
1987-04-03
Date received
1987-03-18
Regulation
866.1700
Classification name
Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
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 JTZ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K132491MUELLER HINTON AGAREdge Biologicals, Inc.2014-06-30
K963036MUELLER HINTON II BROTH (CATION-ADJUSTED) WITH LYSED HORSE BLOODBecton Dickinson Microbiology Systems1996-10-07
K960420MUELLER HINTON AGAR WITH 5% SHEEP BLOODBecton Dickinson Microbiology Systems1996-04-04
K960313MUELLER HINTON AGAR WITH 2% NACIRemel, L.P.1996-03-25
K945911CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARSBioclinical Systems, Inc.1995-04-04
K941985MUELLER HINTON AGAR W/OXACILLINCarr-Scarborough Microbiologicals, Inc.1994-08-24
K882351MUELLER HINTON AGAR PLATES P3318/1&2/P3418/P34181Lakewood Biochemical Co., Inc.1988-06-28
K880105MULLER HINTON BROTHHardy Media1988-03-30
K873268MUELLER HINTON MEDIACentral Media1987-11-04
K870649MRSA SCREEN AGAR (MUELLER HINTON W/NACL & OXACIL.)Hardy Media1987-04-14
K864248MUELLER HINTON AGAR - SUPPLEMENTEDMds Laboratories, Inc.1987-03-31
K864247MUELLER HINTON AGAR WITH 5% SHEEP BLOODMds Laboratories, Inc.1987-03-31
K864246MUELLER HINTON AGAR LARGEMds Laboratories, Inc.1987-03-31
K864245MUELLER HINTON AGAR SMALLMds Laboratories, Inc.1987-03-31
K863821MUELLER HINTON AGAR W/4%NACL AND OXACILLINGibco Laboratories Life Technologies, Inc.1986-10-09