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FDA 510(k)

SYNCHRON CREATININE TRIGGERED TEST CX4,5,7,

K-Number: K915077 · 1991-12-18

ApplicantBeckman Instruments, Inc.
Decision Date1991-12-18
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SYNCHRON CREATININE TRIGGERED TEST CX4,5,7, 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 1991-12-18 under 510(k) number K915077. The device is classified under product code CGX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNCHRON CREATININE TRIGGERED TEST CX4,5,7,?

SYNCHRON CREATININE TRIGGERED TEST CX4,5,7, is a medical device that received FDA 510(k) clearance on 1991-12-18. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K915077.

When did SYNCHRON CREATININE TRIGGERED TEST CX4,5,7, receive FDA 510(k) clearance?

SYNCHRON CREATININE TRIGGERED TEST CX4,5,7, received FDA 510(k) clearance on 1991-12-18, under 510(k) number K915077.

Who is the listed applicant for SYNCHRON CREATININE TRIGGERED TEST CX4,5,7,?

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 CREATININE TRIGGERED TEST CX4,5,7,?

The FDA product code for SYNCHRON CREATININE TRIGGERED TEST CX4,5,7, is CGX.

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Other records listing Beckman Instruments, Inc. as applicant

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Related Devices (Code: CGX)

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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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