CHEMWELL, MODEL 2900— 510(k) K010877
Substantially EquivalentAwareness Technology, Inc.
FDA 510(k) clearance K010877 for CHEMWELL, MODEL 2900, Substantially Equivalent on 2001-05-23. Applicant: Awareness Technology, Inc.. Device class: 2.
Clearance details
- Applicant
- Awareness Technology, Inc.
- Product code
- Code CIX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1035
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Palm City, FL, US
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