510(k) K020226
- Device
- XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT; CATALOG NUMBERS S1383.01, S1383.02 & S1383.03
- Applicant
- Hellen Professional Services
- 510(k) number
- K020226
- Product code
- JWZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-08-22
- Date received
- 2002-01-22
- Regulation
- 866.2660
- Classification name
- Kit, Screening, Trichomonas
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- ROBIN HELLEN
- Address
- 9418 Lasaine Ave. Northridge CA US 91325 91325
FDA Registration Numbers#
- 2029372
- 3017772438
- 2030538
- 1924669
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JWZ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K033864 | GENZYME OSOM TRICHOMONAS RAPID TEST | Genzyme Corp. | 2004-04-02 |
| K020595 | XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01 | Xenotope Diagnostics, Inc. | 2003-02-20 |
| K894246 | MERIVIEW TM TRICHOMONAS | Meridian Diagnostics, Inc. | 1989-08-15 |
| K892802 | SUPER DUO | Mercia Diagnostics , Ltd. | 1989-06-13 |
| K892263 | MERIFLUOR(TM) -TRICHOMONAS | Meridian Diagnostics, Inc. | 1989-05-24 |
| K875138 | TRICHOMATE(R) SUPER | Mercia Diagnostics , Ltd. | 1988-05-13 |
| K874259 | TRICHOMONAS DIRECT ENZYME IMMUNOASSAY | California Integrated Diagnostics, Inc. | 1987-12-07 |
| K871279 | MODIFIED TRICHOMONAS DIRECT SPECIMEN TEST KIT | California Integrated Diagnostics, Inc. | 1987-04-08 |
| K852665 | SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY | Syncor Intl. Corp. | 1985-08-13 |
| K830497 | PEM-T | Hedeco | 1983-04-05 |