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

Kit, Screening, Staphylococcus Aureus

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

JWX is the FDA product code for Kit, Screening, Staphylococcus Aureus, a class I device type, regulated under 21 CFR 866.2660. As of , FDA records hold 20 510(k) clearances under this code, the most recent dated , and 7 recalls.

Classification record

Product code
JWX
Device name
Kit, Screening, Staphylococcus Aureus
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
20
Ingested recalls
7

Clearances, product code JWX

By decision year
20 clearances under product code JWX with a decision year between 1981 and 2009, 1982 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code JWX by decision year
YearClearances
19811
19824
19832
19841
19851
19862
19871
19901
19911
19921
19931
19951
19972
20091

Applicants with the most clearances

Product code JWX
Applicants holding the most 510(k) clearances under product code JWX
ApplicantClearances
Advanced Medical Technology, Inc.1
American Micro Scan1
BD Becton Dickinson Vacutainer Systems Preanalytic1
Binax, Inc.1
Biomerieux Vitek, Inc.1
Connecticut Diagnostics, Ltd.1
Difco Laboratories, Inc.1
Dms Laboratories1
Granite Diagnostics, Inc.1
IMMY, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code