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FDA 510(k)

CREATININE REAGENT FOR AU5000 CLIN LAB ANAL-MODIFY

K-Number: K901298 · 1990-04-25

ApplicantOlympus Corp.
Decision Date1990-04-25
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CREATININE REAGENT FOR AU5000 CLIN LAB ANAL-MODIFY is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Corp.. It received FDA 510(k) clearance on 1990-04-25 under 510(k) number K901298. 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 CREATININE REAGENT FOR AU5000 CLIN LAB ANAL-MODIFY?

CREATININE REAGENT FOR AU5000 CLIN LAB ANAL-MODIFY is a medical device that received FDA 510(k) clearance on 1990-04-25. The listed applicant is Olympus Corp.. The 510(k) number is K901298.

When did CREATININE REAGENT FOR AU5000 CLIN LAB ANAL-MODIFY receive FDA 510(k) clearance?

CREATININE REAGENT FOR AU5000 CLIN LAB ANAL-MODIFY received FDA 510(k) clearance on 1990-04-25, under 510(k) number K901298.

Who is the listed applicant for CREATININE REAGENT FOR AU5000 CLIN LAB ANAL-MODIFY?

The FDA 510(k) record lists Olympus Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CREATININE REAGENT FOR AU5000 CLIN LAB ANAL-MODIFY?

The FDA product code for CREATININE REAGENT FOR AU5000 CLIN LAB ANAL-MODIFY is CGX.

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Other records listing Olympus Corp. as applicant

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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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