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FDA 510(k)

UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100

K-Number: K023764 · 2003-01-28

ApplicantBeckman Coulter, Inc.
Decision Date2003-01-28
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100 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 2003-01-28 under 510(k) number K023764. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100?

UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100 is a medical device that received FDA 510(k) clearance on 2003-01-28. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K023764.

When did UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100 receive FDA 510(k) clearance?

UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100 received FDA 510(k) clearance on 2003-01-28, under 510(k) number K023764.

Who is the listed applicant for UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100?

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 UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100?

The FDA product code for UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100 is JJE.

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Related Devices (Code: JJE)

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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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