A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC
FDA 510(k) clearance K090413 · decided 2009-05-14
Clearance details
- K-number
- K090413
- Device name
- A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC
- Applicant
- Bayer Healthcare, LLC
- Decision
- Substantially Equivalent
- Date received
- 2009-02-18
- Decision date
- 2009-05-14
- Days to decision
- 85 days
- Clearance type
- Special
- Product code
- LCP
- Device class
- 2
- Regulation number
- 864.7470
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device ( recall (Z-0223-2025) | Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. | 2024-10-24 |
| Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610); Hemoglobi recall (Z-0136-2014) | Bayer Healthcare Llc | 2013-11-02 |
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 |