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FDA 510(k)

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

K-Number: K051435 · 2006-01-19

ApplicantClinical Micro Sensors
Decision Date2006-01-19
Product CodeNUA
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYSTEM, MODEL 4800 is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Micro Sensors. It received FDA 510(k) clearance on 2006-01-19 under 510(k) number K051435. The device is classified under product code NUA. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYSTEM, MODEL 4800?

ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYSTEM, MODEL 4800 is a medical device that received FDA 510(k) clearance on 2006-01-19. The listed applicant is Clinical Micro Sensors. The 510(k) number is K051435.

When did ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYSTEM, MODEL 4800 receive FDA 510(k) clearance?

ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYSTEM, MODEL 4800 received FDA 510(k) clearance on 2006-01-19, under 510(k) number K051435.

Who is the listed applicant for ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYSTEM, MODEL 4800?

The FDA 510(k) record lists Clinical Micro Sensors as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYSTEM, MODEL 4800?

The FDA product code for ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYSTEM, MODEL 4800 is NUA.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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