GENZYME OSOM TRICHOMONAS RAPID TEST
FDA 510(k) clearance K033864 · decided 2004-04-02
Clearance details
- K-number
- K033864
- Device name
- GENZYME OSOM TRICHOMONAS RAPID TEST
- Applicant
- Genzyme Corp.
- Decision
- Substantially Equivalent
- Date received
- 2003-12-12
- Decision date
- 2004-04-02
- Days to decision
- 112 days
- Clearance type
- Traditional
- Product code
- JWZ
- Device class
- 1
- Regulation number
- 866.2660
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Cambridge, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01 (K020595) | Xenotope Diagnostics, Inc. | 2003-02-20 |
| XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT; CATALOG NUMBERS S1383.01, S1383.02 & S1383.03 (K020226) | Hellen Professional Services | 2002-08-22 |
| MERIVIEW TM TRICHOMONAS (K894246) | Meridian Diagnostics, Inc. | 1989-08-15 |
| SUPER DUO (K892802) | Mercia Diagnostics , Ltd. | 1989-06-13 |
| MERIFLUOR(TM) -TRICHOMONAS (K892263) | Meridian Diagnostics, Inc. | 1989-05-24 |
| TRICHOMATE(R) SUPER (K875138) | Mercia Diagnostics , Ltd. | 1988-05-13 |
| TRICHOMONAS DIRECT ENZYME IMMUNOASSAY (K874259) | California Integrated Diagnostics, Inc. | 1987-12-07 |
| MODIFIED TRICHOMONAS DIRECT SPECIMEN TEST KIT (K871279) | California Integrated Diagnostics, Inc. | 1987-04-08 |
| SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY (K852665) | Syncor Intl. Corp. | 1985-08-13 |
| PEM-T (K830497) | Hedeco | 1983-04-05 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| LEGOO (P110003/S004) | Genzyme Corp. | 2014-03-26 |
| LEGOO (P110003/S003) | Genzyme Corp. | 2012-11-13 |
| LEGOO ENDOVASCULAR OCCLUSION GEL (P110003/S002) | Genzyme Corp. | 2012-11-13 |
| LEGOO ENDOVASCULAR OCCLUDER (P110003/S001) | Genzyme Corp. | 2012-03-01 |
| LEGOO (P110003) | Genzyme Corp. | 2011-09-28 |
| FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT (P990028/S007) | Genzyme Corp. | 2003-12-04 |
| FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT (P990028/S006) | Genzyme Corp. | 2003-02-04 |
| FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT (P990028/S005) | Genzyme Corp. | 2002-11-25 |