ACCUTNI QC ON THE ACCESS IMMUNOASSAY SYSTEM #33349
FDA 510(k) clearance K010428 · decided 2001-03-13
Clearance details
- K-number
- K010428
- Device name
- ACCUTNI QC ON THE ACCESS IMMUNOASSAY SYSTEM #33349
- Applicant
- Beckman Coulter, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-02-13
- Decision date
- 2001-03-13
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- JJX
- Device class
- 1
- Regulation number
- 862.1660
- 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
No recalls on record reference this clearance.
PMA approvals by this applicant
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|---|---|---|
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| Access Hybritech PSA Reagents on the Access Immunoassay Systems (P850048/S057) | Beckman Coulter, Inc. | 2022-12-16 |