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FDA 510(k)

FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208

K-Number: K060774 · 2006-04-21

ApplicantBeckman Coulter, Inc.
Decision Date2006-04-21
Product CodeCGN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208 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 2006-04-21 under 510(k) number K060774. The device is classified under product code CGN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208?

FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208 is a medical device that received FDA 510(k) clearance on 2006-04-21. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K060774.

When did FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208 receive FDA 510(k) clearance?

FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208 received FDA 510(k) clearance on 2006-04-21, under 510(k) number K060774.

Who is the listed applicant for FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208?

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 FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208?

The FDA product code for FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208 is CGN.

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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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