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FDA 510(k)

SYNCHRON C-REACTIVE PROTEIN REAGENT

K-Number: K910535 · 1991-04-12

ApplicantBeckman Instruments, Inc.
Decision Date1991-04-12
Product CodeDCN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SYNCHRON C-REACTIVE PROTEIN REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Instruments, Inc.. It received FDA 510(k) clearance on 1991-04-12 under 510(k) number K910535. The device is classified under product code DCN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNCHRON C-REACTIVE PROTEIN REAGENT?

SYNCHRON C-REACTIVE PROTEIN REAGENT is a medical device that received FDA 510(k) clearance on 1991-04-12. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K910535.

When did SYNCHRON C-REACTIVE PROTEIN REAGENT receive FDA 510(k) clearance?

SYNCHRON C-REACTIVE PROTEIN REAGENT received FDA 510(k) clearance on 1991-04-12, under 510(k) number K910535.

Who is the listed applicant for SYNCHRON C-REACTIVE PROTEIN REAGENT?

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

What is the FDA product code for SYNCHRON C-REACTIVE PROTEIN REAGENT?

The FDA product code for SYNCHRON C-REACTIVE PROTEIN REAGENT is DCN.

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Other records listing Beckman Instruments, Inc. as applicant

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Related Devices (Code: DCN)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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