MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM
FDA 510(k) clearance K051693 · decided 2005-12-07
Clearance details
- K-number
- K051693
- Device name
- MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM
- Applicant
- Bayer Healthcare, LLC
- Decision
- Substantially Equivalent
- Date received
- 2005-06-23
- Decision date
- 2005-12-07
- Days to decision
- 167 days
- Clearance type
- Traditional
- Product code
- GKL
- Device class
- 2
- Regulation number
- 864.5200
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Tarrytown, NY, US
- Third-party review
- No
- Expedited review
- No
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| SYSMEX POCH-100I (K032677) | Sysmex America, Inc. | 2004-02-11 |
| ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD (K022331) | Bayer Diagnostics Corp. | 2002-09-11 |
| SYSMEX R-500 (K001683) | Sysmex Corporation of America | 2000-08-21 |
| COULTER Z2 ANALYZER (K991070) | Coulter Corp. | 1999-05-11 |
| SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500 (K981950) | Sysmex Corp. | 1998-11-03 |
| SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER (K981761) | Sysmex Corp. | 1998-08-14 |
| ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEM (K971998) | Bayer Corp. | 1997-08-29 |
| SYSMEX SE/RAM-1 (K964375) | Sysmex Corp. | 1997-03-13 |
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 |