The following data is part of a premarket notification filed by Genzyme Corp. with the FDA for Genzyme Osom Trichomonas Rapid Test.
| Device ID | K033864 |
| 510k Number | K033864 |
| Device Name: | GENZYME OSOM TRICHOMONAS RAPID TEST |
| Classification | Kit, Screening, Trichomonas |
| Applicant | GENZYME CORP. ONE KENDALL SQUARE Cambridge, MA 02139 |
| Contact | E.v. Goorchenko |
| Correspondent | E.v. Goorchenko GENZYME CORP. ONE KENDALL SQUARE Cambridge, MA 02139 |
| Product Code | JWZ |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-12 |
| Decision Date | 2004-04-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00742860100130 | K033864 | 000 |
| 00742860100123 | K033864 | 000 |
| 00742860001819 | K033864 | 000 |