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FDA 510(k)

ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL #33340, 33345

K-Number: K021814 · 2002-09-27

ApplicantBeckman Coulter, Inc.
Decision Date2002-09-27
Product CodeMMI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL #33340, 33345 is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2002-09-27 under 510(k) number K021814. The device is classified under product code MMI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL #33340, 33345?

ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL #33340, 33345 is a medical device that received FDA 510(k) clearance on 2002-09-27. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K021814.

When did ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL #33340, 33345 receive FDA 510(k) clearance?

ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL #33340, 33345 received FDA 510(k) clearance on 2002-09-27, under 510(k) number K021814.

Who is the listed applicant for ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL #33340, 33345?

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

What is the FDA product code for ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL #33340, 33345?

The FDA product code for ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL #33340, 33345 is MMI.

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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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