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FDA 510(k)

ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM

K-Number: K111371 · 2011-10-06

ApplicantACON Laboratories, Inc.
Decision Date2011-10-06
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is ACON Laboratories, Inc.. It received FDA 510(k) clearance on 2011-10-06 under 510(k) number K111371. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM?

ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2011-10-06. The listed applicant is ACON Laboratories, Inc.. The 510(k) number is K111371.

When did ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM receive FDA 510(k) clearance?

ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM received FDA 510(k) clearance on 2011-10-06, under 510(k) number K111371.

Who is the listed applicant for ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM?

The FDA 510(k) record lists ACON Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM?

The FDA product code for ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM is CGA.

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Official Source

View on FDA Database →

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

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