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FDA 510(k)

OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117

K-Number: K061575 · 2006-10-05

ApplicantOlympus America, Inc.
Decision Date2006-10-05
Product CodeCJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117 is the device name listed in this FDA 510(k) record. The listed applicant is Olympus America, Inc.. It received FDA 510(k) clearance on 2006-10-05 under 510(k) number K061575. The device is classified under product code CJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117?

OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117 is a medical device that received FDA 510(k) clearance on 2006-10-05. The listed applicant is Olympus America, Inc.. The 510(k) number is K061575.

When did OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117 receive FDA 510(k) clearance?

OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117 received FDA 510(k) clearance on 2006-10-05, under 510(k) number K061575.

Who is the listed applicant for OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117?

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

What is the FDA product code for OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117?

The FDA product code for OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117 is CJY.

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Related Devices (Code: CJY)

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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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