JTZ · Class II · 21 CFR 866.1700

FDA Product Code JTZ: Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth

Leading manufacturers include Hardy Media, Biomedia, Inc. and Mds Laboratories, Inc..

75
Total
75
Cleared
50d
Avg days
1978
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 80d recently vs 50d historically

FDA 510(k) Cleared Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth Devices (Product Code JTZ)

75 devices
1–24 of 75
Cleared Sep 14, 2026
BD BBL Mueller Hinton II Broth (Cation-Adjusted)
K262163
Becton, Dickinson and Company
Microbiology · 80d
Cleared Jun 30, 2014
MUELLER HINTON AGAR
K132491
Edge Biologicals, Inc.
Microbiology · 326d
Cleared Oct 07, 1996
MUELLER HINTON II BROTH (CATION-ADJUSTED) WITH LYSED HORSE BLOOD
K963036
Becton Dickinson Microbiology Systems
Microbiology · 63d
Cleared Apr 04, 1996
MUELLER HINTON AGAR WITH 5% SHEEP BLOOD
K960420
Becton Dickinson Microbiology Systems
Microbiology · 66d
Cleared Mar 25, 1996
MUELLER HINTON AGAR WITH 2% NACI
K960313
Remel, L.P.
Microbiology · 63d
Cleared Apr 04, 1995
CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARS
K945911
Bioclinical Systems, Inc.
Microbiology · 123d
Cleared Aug 24, 1994
MUELLER HINTON AGAR W/OXACILLIN
K941985
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 121d
Cleared Jun 28, 1988
MUELLER HINTON AGAR PLATES P3318/1&2/P3418/P34181
K882351
Lakewood Biochemical Co., Inc.
Microbiology · 21d
Cleared Mar 30, 1988
MULLER HINTON BROTH
K880105
Hardy Media
Microbiology · 84d
Cleared Nov 04, 1987
MUELLER HINTON MEDIA
K873268
Central Media
Microbiology · 85d
Cleared Apr 14, 1987
MRSA SCREEN AGAR (MUELLER HINTON W/NACL & OXACIL.)
K870649
Hardy Media
Microbiology · 60d
Cleared Apr 03, 1987
CHOCOLATE MUELLER HINTON AGAR
K871097
bioMerieux, Inc.
Microbiology · 16d
Cleared Mar 31, 1987
MUELLER HINTON AGAR SMALL
K864245
Mds Laboratories, Inc.
Microbiology · 154d
Cleared Mar 31, 1987
MUELLER HINTON AGAR LARGE
K864246
Mds Laboratories, Inc.
Microbiology · 154d
Cleared Mar 31, 1987
MUELLER HINTON AGAR WITH 5% SHEEP BLOOD
K864247
Mds Laboratories, Inc.
Microbiology · 154d
Cleared Mar 31, 1987
MUELLER HINTON AGAR - SUPPLEMENTED
K864248
Mds Laboratories, Inc.
Microbiology · 154d
Cleared Oct 09, 1986
MUELLER HINTON AGAR W/4%NACL AND OXACILLIN
K863821
Gibco Laboratories Life Technologies, Inc.
Microbiology · 9d
Cleared Apr 21, 1986
BACTI PLATE (DERMATOLOGY) PRODUCT NO. PS-5000
K861301
Troy Biologicals, Inc.
Microbiology · 14d
Cleared Dec 23, 1985
BIOGRAM
K854521
Giles Scientific, Inc.
Microbiology · 41d
Cleared Nov 18, 1985
MUELLER HINTON MEDIUM
K854451
R. Kent Richards, Inc.
Microbiology · 13d
Cleared Aug 19, 1985
APL MUELLER HINTON AGAR
K853238
Apl Medical Supplies
Microbiology · 18d
Cleared Aug 13, 1985
URINE DUO
K851225
Culture Kits, Inc.
Microbiology · 140d
Cleared May 10, 1985
MUELLER HINTON AGAR W/4% NACL W/ANTIBIOTICS
K850291
Remel Co.
Microbiology · 106d
Cleared Apr 30, 1985
MUELLER HINTON AGAR & MUELLER HINTON AGAR W/5% SHE
K851589
Preferred Micro-Media
Microbiology · 14d

About Product Code JTZ - Regulatory Context

510(k) Submission Activity

75 total 510(k) submissions under product code JTZ since 1978, with 75 receiving FDA clearance (average review time: 50 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - JTZ Product Code

Recent submissions under JTZ have taken an average of 80 days to reach a decision - up from 50 days historically. Manufacturers should account for longer review timelines in current project planning.

JTZ devices are reviewed by the Microbiology panel. Browse all Microbiology devices →