TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM
FDA 510(k) clearance K052503 · decided 2005-12-14
Clearance details
- K-number
- K052503
- Device name
- TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM
- Applicant
- Bayer Healthcare, LLC
- Decision
- Substantially Equivalent
- Date received
- 2005-09-13
- Decision date
- 2005-12-14
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- MMI
- Device class
- 2
- Regulation number
- 862.1215
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Tarrytown, NY, 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 |
|---|---|---|
| ADVIA CENTAUR HAV IGM READY PACK REAGENTS, ADVIA CENTAUR HAV IGM QUALITY CONTROL MATERIALS (P040018) | Bayer Healthcare, LLC | 2004-12-22 |
| CIBA CORNING ACS PSA IMMUNOASSAY (P920030/S002) | Bayer Healthcare, LLC | 1998-12-08 |
| CIBA CORNING ACS PSA IMMUNOASSAY (P920030) | Bayer Healthcare, LLC | 1998-12-08 |
| CIBA CORNING ACS PSA IMMUNOASSAY (P920030/S001) | Bayer Healthcare, LLC | 1995-12-13 |