GENZYME CONTRAST II HCG URINE/SERUM TEST
FDA 510(k) clearance K023544 · decided 2003-01-16
Clearance details
- K-number
- K023544
- Device name
- GENZYME CONTRAST II HCG URINE/SERUM TEST
- Applicant
- Genzyme Corp.
- Decision
- Substantially Equivalent
- Date received
- 2002-10-22
- Decision date
- 2003-01-16
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- JHI
- Device class
- 2
- Regulation number
- 862.1155
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Cambridge, MA, US
- Third-party review
- No
- Expedited review
- No
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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 |