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FDA 510(k)

ON CALL CHOSEN LANCING DEVICE

K-Number: K113332 · 2012-04-18

ApplicantACON Laboratories, Inc.
Decision Date2012-04-18
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ON CALL CHOSEN LANCING DEVICE 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 2012-04-18 under 510(k) number K113332. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ON CALL CHOSEN LANCING DEVICE?

ON CALL CHOSEN LANCING DEVICE is a medical device that received FDA 510(k) clearance on 2012-04-18. The listed applicant is ACON Laboratories, Inc.. The 510(k) number is K113332.

When did ON CALL CHOSEN LANCING DEVICE receive FDA 510(k) clearance?

ON CALL CHOSEN LANCING DEVICE received FDA 510(k) clearance on 2012-04-18, under 510(k) number K113332.

Who is the listed applicant for ON CALL CHOSEN LANCING DEVICE?

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 LANCING DEVICE?

The FDA product code for ON CALL CHOSEN LANCING DEVICE is FMK.

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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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