Genzyme Osom Trichomonas Rapid Test
FDA 510(k) K033864 · Genzyme Corp.
510(k) numberK033864
Submission
- Device name
- Genzyme Osom Trichomonas Rapid Test
- Applicant
- Genzyme Corp.
Cambridge, MA, US - Received
- December 12, 2003
- Decision date
- April 2, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JWZ – Kit, Screening, Trichomonas
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
Other 510(k)s with product code JWZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K020595 | Xenostrip-Tv Trichomonas Cassette Test, Model C1383.01JWZ · Traditional | Xenotope Diagnostics, Inc. | 02/20/2003SE |
| K020226 | Xenostrip-Tv Trichomonas Diagnostic Test Kit; Catalog Numbers S1383.01, S1383.02 &…JWZ · Traditional | Hellen Professional Services | 08/22/2002SE |
| K894246 | Meriview TM TrichomonasJWZ · Traditional | Meridian Diagnostics, Inc. | 08/15/1989SE |
| K892802 | Super DuoJWZ · Traditional | Mercia Diagnostics , Ltd. | 06/13/1989SE |
| K892263 | Merifluor(Tm) -TrichomonasJWZ · Traditional | Meridian Diagnostics, Inc. | 05/24/1989SE |
| K875138 | Trichomate(R) SuperJWZ · Traditional | Mercia Diagnostics , Ltd. | 05/13/1988SE |
| K874259 | Trichomonas Direct Enzyme ImmunoassayJWZ · Traditional | California Integrated Diagnostics, Inc. | 12/07/1987SE |
| K871279 | Modified Trichomonas Direct Specimen Test KitJWZ · Traditional | California Integrated Diagnostics, Inc. | 04/08/1987SE |
| K852665 | Syncor Trich Direct Immunofluorescence AssayJWZ · Traditional | Syncor Intl. Corp. | 08/13/1985SE |
| K830497 | Pem-TJWZ · Traditional | Hedeco | 04/05/1983SE |
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Questions and answers
When was Genzyme Osom Trichomonas Rapid Test cleared by the FDA?
Genzyme Osom Trichomonas Rapid Test (K033864) received a 510(k) decision of Substantially Equivalent on April 2, 2004, 112 days after the submission was received.
What is the product code of K033864?
The FDA product code is JWZ – Kit, Screening, Trichomonas, a Class I (low risk) device regulated under 21 CFR 866.2660.