ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
FDA 510(k) clearance K973966 · decided 1997-10-31
Clearance details
- K-number
- K973966
- Device name
- ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
- Applicant
- Beckman Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-10-17
- Decision date
- 1997-10-31
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- CDP
- Device class
- 2
- Regulation number
- 862.1710
- 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 Total T3 Triiodothyronine , REF 33830 ( recall (Z-2239-2020) | Beckman Coulter Inc. | 2020-06-02 |
| Access Total T3 Reagent, PN: 33830 The Access Total T3 assay is used for the quantitative recall (Z-2227-2012) | Beckman Coulter Inc. | 2012-08-20 |