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FDA 510(k)

MILES URINE GLUCOSE METHOD

K-Number: K923040 · 1992-09-15

ApplicantHeraeus Kulzer, Inc.
Decision Date1992-09-15
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MILES URINE GLUCOSE METHOD is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer, Inc.. It received FDA 510(k) clearance on 1992-09-15 under 510(k) number K923040. The device is classified under product code CFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MILES URINE GLUCOSE METHOD?

MILES URINE GLUCOSE METHOD is a medical device that received FDA 510(k) clearance on 1992-09-15. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K923040.

When did MILES URINE GLUCOSE METHOD receive FDA 510(k) clearance?

MILES URINE GLUCOSE METHOD received FDA 510(k) clearance on 1992-09-15, under 510(k) number K923040.

Who is the listed applicant for MILES URINE GLUCOSE METHOD?

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

What is the FDA product code for MILES URINE GLUCOSE METHOD?

The FDA product code for MILES URINE GLUCOSE METHOD is CFR.

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Related Devices (Code: CFR)

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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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