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FDA 510(k)

BECKMAN PARAGON(TM) CREATINE KINASE ISOENZYME

K-Number: K893269 · 1989-07-20

ApplicantBeckman Instruments, Inc.
Decision Date1989-07-20
Product CodeCGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BECKMAN PARAGON(TM) CREATINE KINASE ISOENZYME 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 1989-07-20 under 510(k) number K893269. The device is classified under product code CGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BECKMAN PARAGON(TM) CREATINE KINASE ISOENZYME?

BECKMAN PARAGON(TM) CREATINE KINASE ISOENZYME is a medical device that received FDA 510(k) clearance on 1989-07-20. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K893269.

When did BECKMAN PARAGON(TM) CREATINE KINASE ISOENZYME receive FDA 510(k) clearance?

BECKMAN PARAGON(TM) CREATINE KINASE ISOENZYME received FDA 510(k) clearance on 1989-07-20, under 510(k) number K893269.

Who is the listed applicant for BECKMAN PARAGON(TM) CREATINE KINASE ISOENZYME?

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 BECKMAN PARAGON(TM) CREATINE KINASE ISOENZYME?

The FDA product code for BECKMAN PARAGON(TM) CREATINE KINASE ISOENZYME is CGS.

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Other records listing Beckman Instruments, Inc. as applicant

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Related Devices (Code: CGS)

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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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