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

Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar

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

JSO is the FDA product code for Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar, a class II device type, regulated under 21 CFR 866.1700. As of , FDA records hold 40 510(k) clearances under this code, the most recent dated , and 56 recalls.

Classification record

Product code
JSO
Device name
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
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
40
Ingested recalls
56

Clearances, product code JSO

By decision year
40 clearances under product code JSO with a decision year between 1977 and 2019, 2010 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code JSO by decision year
YearClearances
19771
19811
19882
19893
19901
19933
19943
19952
19962
19972
20041
20071
20082
20091
20105
20112
20121
20163
20172
20181
20191

Applicants with the most clearances

Product code JSO
Applicants holding the most 510(k) clearances under product code JSO
ApplicantClearances
Bio-Rad6
Remel Inc6
Hardy Diagnostics5
bioMerieux, Inc.5
BD Becton Dickinson Vacutainer Systems Preanalytic3
Becton Dickinson Microbiology Systems3
Neogen Culture Media2
Becton Dickinson & Co2
Thermo Fisher Scientific Oy2
Carr-Scarborough Microbiologicals, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code