SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS
FDA 510(k) clearance K053401 · decided 2006-03-24
Clearance details
- K-number
- K053401
- Device name
- SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS
- Applicant
- Arkray, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-12-06
- Decision date
- 2006-03-24
- Days to decision
- 108 days
- Clearance type
- Traditional
- Product code
- CIC
- Device class
- 2
- Regulation number
- 862.1145
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Cortlandt Manor, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| arkray SPOTCHEM II Basic Panel - 1 Reagent test strips, Product # 11726, MEDTEST DX Catalo recall (Z-0631-2016) | Arkray Factory USA, Inc. | 2016-01-15 |