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FDA 510(k)

CREATININE ANALYZER 2

K-Number: K771335 · 1977-08-03

ApplicantBeckman Instruments, Inc.
Decision Date1977-08-03
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CREATININE ANALYZER 2 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 1977-08-03 under 510(k) number K771335. 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 CREATININE ANALYZER 2?

CREATININE ANALYZER 2 is a medical device that received FDA 510(k) clearance on 1977-08-03. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K771335.

When did CREATININE ANALYZER 2 receive FDA 510(k) clearance?

CREATININE ANALYZER 2 received FDA 510(k) clearance on 1977-08-03, under 510(k) number K771335.

Who is the listed applicant for CREATININE ANALYZER 2?

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 CREATININE ANALYZER 2?

The FDA product code for CREATININE ANALYZER 2 is CGX.

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Other records listing Beckman Instruments, Inc. as applicant

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Related Devices (Code: CGX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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