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FDA 510(k)

OLYMPUS CK-MB REAGENT

K-Number: K971817 · 1997-06-11

ApplicantOlympus America, Inc.
Decision Date1997-06-11
Product CodeJLB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OLYMPUS CK-MB REAGENT 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 1997-06-11 under 510(k) number K971817. The device is classified under product code JLB. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS CK-MB REAGENT?

OLYMPUS CK-MB REAGENT is a medical device that received FDA 510(k) clearance on 1997-06-11. The listed applicant is Olympus America, Inc.. The 510(k) number is K971817.

When did OLYMPUS CK-MB REAGENT receive FDA 510(k) clearance?

OLYMPUS CK-MB REAGENT received FDA 510(k) clearance on 1997-06-11, under 510(k) number K971817.

Who is the listed applicant for OLYMPUS CK-MB REAGENT?

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 CK-MB REAGENT?

The FDA product code for OLYMPUS CK-MB REAGENT is JLB.

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Other records listing Olympus America, 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.

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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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