Panels › Microbiology › Product code JWZ · Class 1
Kit, Screening, Trichomonas
Regulation 866.2660
0510(k)s in 12 months (11 all time)
1recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in JWZ
| Company | 510(k)s | Recalls |
|---|---|---|
| California Integrated Diagnostics, Inc. | 2 | 0 |
| Mercia Diagnostics , Ltd. | 2 | 0 |
| Meridian Diagnostics, Inc. | 2 | 0 |
| Genzyme Corp. | 1 | 0 |
| GET TESTED INTERNATIONAL AB | 0 | 1 |
| Hedeco | 1 | 0 |
| Hellen Professional Services | 1 | 0 |
| Syncor Intl. Corp. | 1 | 0 |
| Xenotope Diagnostics, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 2, 2004 | K033864 | GENZYME OSOM TRICHOMONAS RAPID TEST Genzyme Corp. | JWZ |
| Feb 20, 2003 | K020595 | XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01 Xenotope Diagnostics, Inc. | JWZ |
| Aug 22, 2002 | K020226 | XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT; CATALOG NUMBERS S1383.01, S1383.02 & S1383.03 Hellen Professional Services | JWZ |
| Aug 15, 1989 | K894246 | MERIVIEW TM TRICHOMONAS Meridian Diagnostics, Inc. | JWZ |
| Jun 13, 1989 | K892802 | SUPER DUO Mercia Diagnostics , Ltd., GB | JWZ |
| May 24, 1989 | K892263 | MERIFLUOR(TM) -TRICHOMONAS Meridian Diagnostics, Inc. | JWZ |
| May 13, 1988 | K875138 | TRICHOMATE(R) SUPER Mercia Diagnostics , Ltd., GB | JWZ |
| Dec 7, 1987 | K874259 | TRICHOMONAS DIRECT ENZYME IMMUNOASSAY California Integrated Diagnostics, Inc. | JWZ |
| Apr 8, 1987 | K871279 | MODIFIED TRICHOMONAS DIRECT SPECIMEN TEST KIT California Integrated Diagnostics, Inc. | JWZ |
| Aug 13, 1985 | K852665 | SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY Syncor Intl. Corp. | JWZ |
| Apr 5, 1983 | K830497 | PEM-T Hedeco | JWZ |
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