ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505
FDA 510(k) clearance K980173 · decided 1998-03-18
Clearance details
- K-number
- K980173
- Device name
- ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505
- Applicant
- Beckman Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-01-20
- Decision date
- 1998-03-18
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- JHI
- Device class
- 2
- Regulation number
- 862.1155
- 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 Total BhCG (BhCG) Assay Part Number 33500 The Access Total BhCG assay is a paramagn recall (Z-1736-2011) | Beckman Coulter Inc. | 2011-03-21 |