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FDA 510(k)

CX(TM) COCAINE METABOLITE(COCM) REAGENT/SYNCHRON CX SYS

K-Number: K944087 · 1994-11-30

ApplicantBeckman Instruments, Inc.
Decision Date1994-11-30
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CX(TM) COCAINE METABOLITE(COCM) REAGENT/SYNCHRON CX SYS 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 1994-11-30 under 510(k) number K944087. The device is classified under product code DIO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CX(TM) COCAINE METABOLITE(COCM) REAGENT/SYNCHRON CX SYS?

CX(TM) COCAINE METABOLITE(COCM) REAGENT/SYNCHRON CX SYS is a medical device that received FDA 510(k) clearance on 1994-11-30. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K944087.

When did CX(TM) COCAINE METABOLITE(COCM) REAGENT/SYNCHRON CX SYS receive FDA 510(k) clearance?

CX(TM) COCAINE METABOLITE(COCM) REAGENT/SYNCHRON CX SYS received FDA 510(k) clearance on 1994-11-30, under 510(k) number K944087.

Who is the listed applicant for CX(TM) COCAINE METABOLITE(COCM) REAGENT/SYNCHRON CX SYS?

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 CX(TM) COCAINE METABOLITE(COCM) REAGENT/SYNCHRON CX SYS?

The FDA product code for CX(TM) COCAINE METABOLITE(COCM) REAGENT/SYNCHRON CX SYS is DIO.

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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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