ACTIN FSL ACTIVATED PTT REAGENT
FDA 510(k) clearance K863594 · decided 1986-10-17
Clearance details
- K-number
- K863594
- Device name
- ACTIN FSL ACTIVATED PTT REAGENT
- Applicant
- American Dade
- Decision
- Substantially Equivalent
- Date received
- 1986-09-15
- Decision date
- 1986-10-17
- Days to decision
- 32 days
- Clearance type
- Traditional
- Product code
- GGW
- Device class
- 2
- Regulation number
- 864.7925
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Santa Ana, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Dade(R) Actin(R) FSL Activated PTT Reagent. For use in the determination of the activated recall (Z-1073-2013) | Siemens Healthcare Diagnostics, Inc. | 2013-04-09 |
| Dade(R) Actin(R) FSL Activated PTT Reagent Product Usage: Liquid purified soy and rabbit b recall (Z-1043-2012) | Siemens Healthcare Diagnostics, Inc. | 2012-02-16 |