Atlas FDA

ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYSTEM, MODEL 4800

FDA 510(k) clearance K051435 · decided 2006-01-19

Clearance details

K-number
K051435
Device name
ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYSTEM, MODEL 4800
Applicant
Clinical Micro Sensors
Decision
Substantially Equivalent
Date received
2005-06-01
Decision date
2006-01-19
Days to decision
232 days
Clearance type
Traditional
Product code
NUA
Device class
2
Regulation number
866.5900
Medical specialty
Immunology
Advisory committee
Immunology
Location
Pasadena, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.