WAKO AUTOKIT LP(A)
FDA 510(k) clearance K981446 · decided 1999-03-09
Clearance details
- K-number
- K981446
- Device name
- WAKO AUTOKIT LP(A)
- Applicant
- Wako Chemicals USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-04-22
- Decision date
- 1999-03-09
- Days to decision
- 321 days
- Clearance type
- Traditional
- Product code
- DFC
- Device class
- 2
- Regulation number
- 866.5600
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Richmond, VA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Wako Autokit Lp(a) Calibrator, model code# 998-41491, packaged in 1 ml bottles, 2 bottles/ recall (Z-1377-2012) | Wako Chemicals USA, Inc. | 2012-04-06 |
| Lp(a) Calibrator, Cat No. 998-41491, 1 ml glass bottles, in cardboard box, 2 bottles/box , recall (Z-1409-06) | Wako Chemicals, USA Inc | 2006-08-25 |