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FDA 510(k)

MILES URINE CREATININE METHOD

K-Number: K923039 · 1992-08-24

ApplicantHeraeus Kulzer, Inc.
Decision Date1992-08-24
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MILES URINE CREATININE 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 1992-08-24 under 510(k) number K923039. The device is classified under product code CGX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MILES URINE CREATININE METHOD?

MILES URINE CREATININE METHOD is a medical device that received FDA 510(k) clearance on 1992-08-24. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K923039.

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

MILES URINE CREATININE METHOD received FDA 510(k) clearance on 1992-08-24, under 510(k) number K923039.

Who is the listed applicant for MILES URINE CREATININE 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 CREATININE METHOD?

The FDA product code for MILES URINE CREATININE METHOD is CGX.

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Other records listing Heraeus Kulzer, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K091494FLEXITIME FLOWK063062HKBOND 2006K060994MONDIALK052543HERACERAM ZIRKONIAK043504PALAIMPACTK043295VERSYO.DIRECT

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Related Devices (Code: CGX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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