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FDA 510(k)

ACCESS TOTAL BHCG

K-Number: K023480 · 2002-12-20

ApplicantBeckman Coulter, Inc.
Decision Date2002-12-20
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACCESS TOTAL BHCG 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 2002-12-20 under 510(k) number K023480. The device is classified under product code JHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCESS TOTAL BHCG?

ACCESS TOTAL BHCG is a medical device that received FDA 510(k) clearance on 2002-12-20. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K023480.

When did ACCESS TOTAL BHCG receive FDA 510(k) clearance?

ACCESS TOTAL BHCG received FDA 510(k) clearance on 2002-12-20, under 510(k) number K023480.

Who is the listed applicant for ACCESS TOTAL BHCG?

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 ACCESS TOTAL BHCG?

The FDA product code for ACCESS TOTAL BHCG is JHI.

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Related Devices (Code: JHI)

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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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