ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
FDA 510(k) clearance K982250 · decided 1998-07-14
Clearance details
- K-number
- K982250
- Device name
- ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
- Applicant
- Beckman Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-06-26
- Decision date
- 1998-07-14
- Days to decision
- 18 days
- Clearance type
- Traditional
- Product code
- CEC
- Device class
- 2
- Regulation number
- 862.1695
- 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 |
|---|---|---|
| Beckman Coulter Access Immunoassay Systems, Access Free T4 Thyroxine, REF 33880 (UDI:15099 recall (Z-2237-2020) | Beckman Coulter Inc. | 2020-06-02 |
| Access Free T4 Calibrator, Part Number: 33885, Lot Numbers: 014769 The Access Free T4 Cali recall (Z-1945-2011) | Beckman Coulter Inc. | 2011-04-11 |
| Access Immunoassay Systems Free T4, Part Number: 33880 recall (Z-2658-2010) | Beckman Coulter Inc. | 2010-10-01 |