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FDA 510(k)

ARRAY 360 SYSTEM C-REACTIVE PROTEIN (CRP MPE) REAGENT

K-Number: K990704 · 1999-05-03

ApplicantBeckman Coulter, Inc.
Decision Date1999-05-03
Product CodeDCK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ARRAY 360 SYSTEM C-REACTIVE PROTEIN (CRP MPE) REAGENT 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 1999-05-03 under 510(k) number K990704. The device is classified under product code DCK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARRAY 360 SYSTEM C-REACTIVE PROTEIN (CRP MPE) REAGENT?

ARRAY 360 SYSTEM C-REACTIVE PROTEIN (CRP MPE) REAGENT is a medical device that received FDA 510(k) clearance on 1999-05-03. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K990704.

When did ARRAY 360 SYSTEM C-REACTIVE PROTEIN (CRP MPE) REAGENT receive FDA 510(k) clearance?

ARRAY 360 SYSTEM C-REACTIVE PROTEIN (CRP MPE) REAGENT received FDA 510(k) clearance on 1999-05-03, under 510(k) number K990704.

Who is the listed applicant for ARRAY 360 SYSTEM C-REACTIVE PROTEIN (CRP MPE) REAGENT?

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 ARRAY 360 SYSTEM C-REACTIVE PROTEIN (CRP MPE) REAGENT?

The FDA product code for ARRAY 360 SYSTEM C-REACTIVE PROTEIN (CRP MPE) REAGENT is DCK.

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Related Devices (Code: DCK)

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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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