ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM # 33340, 33345
FDA 510(k) clearance K010429 · decided 2001-06-05
Clearance details
- K-number
- K010429
- Device name
- ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM # 33340, 33345
- Applicant
- Beckman Coulter, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-02-13
- Decision date
- 2001-06-05
- Days to decision
- 112 days
- Clearance type
- Traditional
- Product code
- MMI
- Device class
- 2
- Regulation number
- 862.1215
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Chaska, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Access Immunoassay Systems enhanced AccuTnl Reagent Kit, Part Number: A78803 The Access Ac recall (Z-1883-2011) | Beckman Coulter Inc. | 2011-04-04 |
| Access Immunoassay Systems enhanced AccuTnl Reagent Kit; Part Number: A78803 The Access Ac recall (Z-1995-2010) | Beckman Coulter Inc. | 2010-07-12 |
| Access Immunoassay Systems Accu Tnl Reagent Kit when used in conjunction with UniCel Dxl A recall (Z-1318-2010) | Beckman Coulter Inc. | 2010-04-12 |
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| Record | Firm | Date |
|---|---|---|
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