ESENSOR CYSTIC FIBROSIS CARRIER DETECTION SYSTEM, MODEL ESENSOR 4800— 510(k) K060543
Substantially EquivalentClinical Micro Sensors, Inc.
FDA 510(k) clearance K060543 for ESENSOR CYSTIC FIBROSIS CARRIER DETECTION SYSTEM, MODEL ESENSOR 4800, Substantially Equivalent on 2006-03-28. Applicant: Clinical Micro Sensors, Inc.. Device class: 2.
Clearance details
- Applicant
- Clinical Micro Sensors, Inc.
- Product code
- Code NUA
- Device class
- Class 2
- Regulation
- 21 CFR 866.5900
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Pasadena, CA, US
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