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

Kit, Screening, Trichomonas

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

JWZ is the FDA product code for Kit, Screening, Trichomonas, a class I device type, regulated under 21 CFR 866.2660. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
JWZ
Device name
Kit, Screening, Trichomonas
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
11
Ingested recalls
1

Clearances, product code JWZ

By decision year
11 clearances under product code JWZ with a decision year between 1983 and 2004, 1989 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code JWZ by decision year
YearClearances
19831
19851
19872
19881
19893
20021
20031
20041

Applicants with the most clearances

Product code JWZ
Applicants holding the most 510(k) clearances under product code JWZ
ApplicantClearances
California Integrated Diagnostics, Inc.2
Mercia Diagnostics, Ltd.2
Meridian Diagnostics, Inc.2
Genzyme Corporation1
Hedeco1
Hellen Professional Services1
Syncor Intl. Corp.1
Xenotope Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code