PTT-LA TEST KIT
FDA 510(k) clearance K921684 · decided 1992-06-09
Clearance details
- K-number
- K921684
- Device name
- PTT-LA TEST KIT
- Applicant
- American Bioproducts Co.
- Decision
- Substantially Equivalent
- Date received
- 1992-04-08
- Decision date
- 1992-06-09
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- GGW
- Device class
- 2
- Regulation number
- 864.7925
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Parsippany, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| PTT-LA. Lupus anticoagulant-sensitive APTT reagent. Diagnostica Stago, 6x 2mL.. Distribute recall (Z-1419-05) | Diagnostica Stago, Inc. | 2005-08-30 |