WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2
FDA 510(k) clearance K040918 · decided 2004-05-17
Clearance details
- K-number
- K040918
- Device name
- WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2
- Applicant
- Wako Chemicals USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-04-08
- Decision date
- 2004-05-17
- Days to decision
- 39 days
- Clearance type
- Traditional
- Product code
- JJX
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Richmond, VA, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| i-STAT CG8+ cartridges The i-stat Hematocrit (Hct) is intended for use in the in vitro qua recall (Z-1792-2010) | Abbott Point of Care Inc. | 2010-06-11 |