Atlas FDA

MUELLER HINTON AGAR LARGE

FDA 510(k) clearance K864246 · decided 1987-03-31

Clearance details

K-number
K864246
Device name
MUELLER HINTON AGAR LARGE
Applicant
Mds Laboratories, Inc.
Decision
Substantially Equivalent
Date received
1986-10-28
Decision date
1987-03-31
Days to decision
154 days
Clearance type
Traditional
Product code
JTZ
Device class
2
Regulation number
866.1700
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
L5j 2m4, CA
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
MUELLER HINTON AGAR (K132491)Edge Biologicals, Inc.2014-06-30
MUELLER HINTON II BROTH (CATION-ADJUSTED) WITH LYSED HORSE BLOOD (K963036)Becton Dickinson Microbiology Systems1996-10-07
MUELLER HINTON AGAR WITH 5% SHEEP BLOOD (K960420)Becton Dickinson Microbiology Systems1996-04-04
MUELLER HINTON AGAR WITH 2% NACI (K960313)Remel, L.P.1996-03-25
CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARS (K945911)Bioclinical Systems, Inc.1995-04-04
MUELLER HINTON AGAR W/OXACILLIN (K941985)Carr-Scarborough Microbiologicals, Inc.1994-08-24
MUELLER HINTON AGAR PLATES P3318/1&2/P3418/P34181 (K882351)Lakewood Biochemical Co., Inc.1988-06-28
MULLER HINTON BROTH (K880105)Hardy Media1988-03-30
MUELLER HINTON MEDIA (K873268)Central Media1987-11-04
MRSA SCREEN AGAR (MUELLER HINTON W/NACL & OXACIL.) (K870649)Hardy Media1987-04-14
CHOCOLATE MUELLER HINTON AGAR (K871097)bioMerieux, Inc.1987-04-03
MUELLER HINTON AGAR WITH 5% SHEEP BLOOD (K864247)Mds Laboratories, Inc.1987-03-31

Recalls involving this device

No recalls on record reference this clearance.