510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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JTZClass II

Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth

21 CFR 866.1700 / Microbiology
FDA source (opens on fda.gov)

JTZ is the FDA product code for Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth, a class II device type, regulated under 21 CFR 866.1700. As of , FDA records hold 74 510(k) clearances under this code, the most recent dated , and 8 recalls.

Classification record

Product code
JTZ
Device name
Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
Regulation
21 CFR 866.1700
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
75
Ingested recalls
8

Clearances, product code JTZ

By decision year
75 clearances under product code JTZ with a decision year between 1978 and 2026, 1985 the highest year at 12.
Show the numbers
510(k) clearances under FDA product code JTZ by decision year
YearClearances
19782
19797
19805
19818
19829
19834
198410
198512
19862
19877
19882
19941
19951
19963
20141
20261

Applicants with the most clearances

Product code JTZ
Applicants holding the most 510(k) clearances under product code JTZ
ApplicantClearances
Biomedia, Inc.5
Hardy Media5
Mds Laboratories, Inc.4
Biomedica, Inc.3
Gibco Laboratories Life Technologies, Inc.3
Interstate Media3
Isle Media and Sterile Products, Inc.3
Neogen Culture Media2
Anaerobe Systems2
Becton Dickinson Microbiology Systems2

Companies listing this code with FDA

Companies whose registered establishments list this code