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FDA 510(k)

ACON U120 URINE ANALYZER, MODEL U111-101

K-Number: K070929 · 2007-07-30

ApplicantACON Laboratories, Inc.
Decision Date2007-07-30
Product CodeKQO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACON U120 URINE ANALYZER, MODEL U111-101 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 2007-07-30 under 510(k) number K070929. The device is classified under product code KQO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACON U120 URINE ANALYZER, MODEL U111-101?

ACON U120 URINE ANALYZER, MODEL U111-101 is a medical device that received FDA 510(k) clearance on 2007-07-30. The listed applicant is ACON Laboratories, Inc.. The 510(k) number is K070929.

When did ACON U120 URINE ANALYZER, MODEL U111-101 receive FDA 510(k) clearance?

ACON U120 URINE ANALYZER, MODEL U111-101 received FDA 510(k) clearance on 2007-07-30, under 510(k) number K070929.

Who is the listed applicant for ACON U120 URINE ANALYZER, MODEL U111-101?

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 ACON U120 URINE ANALYZER, MODEL U111-101?

The FDA product code for ACON U120 URINE ANALYZER, MODEL U111-101 is KQO.

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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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