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

Kit, Identification, Yeast

21 CFR 866.2660 / Microbiology
FDA source (opens on fda.gov)

JXB is the FDA product code for Kit, Identification, Yeast, a class I device type, regulated under 21 CFR 866.2660. As of , FDA records hold 16 510(k) clearances under this code, the most recent dated , and 6 recalls.

Classification record

Product code
JXB
Device name
Kit, Identification, Yeast
Regulation
21 CFR 866.2660
Device class
Class I
Review panel
Microbiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
16
Ingested recalls
6

Clearances, product code JXB

By decision year
16 clearances under product code JXB with a decision year between 1977 and 2008, 1979 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code JXB by decision year
YearClearances
19771
19793
19803
19831
19861
19881
19901
19941
19951
20001
20061
20081

Applicants with the most clearances

Product code JXB
Applicants holding the most 510(k) clearances under product code JXB
ApplicantClearances
Advandx, Inc.2
Analytical Products, Inc.2
Vitek Systems, Inc.2
Abbott Medical1
American Micro Scan1
Diagnostic Markers, Inc.1
Diagnostica, Inc.1
IMMY, Inc.1
Innovative Diagnostic Systems, Inc.1
Medical Wire and Equipment Co. Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code