UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION
FDA 510(k) clearance K100464 · decided 2011-02-23
Clearance details
- K-number
- K100464
- Device name
- UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION
- Applicant
- Wako Chemicals USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-02-18
- Decision date
- 2011-02-23
- Days to decision
- 370 days
- Clearance type
- Traditional
- Product code
- NSF
- Device class
- 2
- Regulation number
- 866.6030
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Mountain View, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Wako Chemicals USA
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS (DEN050002) | Wako Chemicals USA, Inc. | 2005-05-19 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| uTASWako DCP, Lot TG340 2013.11, REF 995-60701, Wako Pure Chemical Industries, Ltd. 1-2 Do recall (Z-1831-2013) | Wako Life Sciences, Inc. | 2013-07-30 |