STAR AUTOMATED MULTI-PARAMETRIC ANALYZER
FDA 510(k) clearance K983460 · decided 1998-11-12
Clearance details
- K-number
- K983460
- Device name
- STAR AUTOMATED MULTI-PARAMETRIC ANALYZER
- Applicant
- American Bioproducts Co.
- Decision
- Substantially Equivalent
- Date received
- 1998-09-30
- Decision date
- 1998-11-12
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- JPA
- Device class
- 2
- Regulation number
- 864.5425
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Parisppany, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| STA-Compact Hemostasis System with Cap piercing capability. recall (Z-0899-03) | Diagnostica Stago, Inc. | 2003-05-29 |