ADVIA 60 HEMATOLOGY ANALYZER
FDA 510(k) clearance K032524 · decided 2003-09-08
Clearance details
- K-number
- K032524
- Device name
- ADVIA 60 HEMATOLOGY ANALYZER
- Applicant
- Bayer Healthcare, LLC
- Decision
- Substantially Equivalent
- Date received
- 2003-08-15
- Decision date
- 2003-09-08
- Days to decision
- 24 days
- Clearance type
- Special
- Product code
- GKZ
- Device class
- 2
- Regulation number
- 864.5220
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- 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 |