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FDA 510(k)

FORESIGHT U120 URINE ANALYZER

K-Number: K120124 · 2012-03-06

ApplicantACON Laboratories, Inc.
Decision Date2012-03-06
Product CodeJIL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FORESIGHT U120 URINE ANALYZER 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 2012-03-06 under 510(k) number K120124. The device is classified under product code JIL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FORESIGHT U120 URINE ANALYZER?

FORESIGHT U120 URINE ANALYZER is a medical device that received FDA 510(k) clearance on 2012-03-06. The listed applicant is ACON Laboratories, Inc.. The 510(k) number is K120124.

When did FORESIGHT U120 URINE ANALYZER receive FDA 510(k) clearance?

FORESIGHT U120 URINE ANALYZER received FDA 510(k) clearance on 2012-03-06, under 510(k) number K120124.

Who is the listed applicant for FORESIGHT U120 URINE ANALYZER?

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 FORESIGHT U120 URINE ANALYZER?

The FDA product code for FORESIGHT U120 URINE ANALYZER is JIL.

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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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