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FDA 510(k)

CREATININE ANALYSIS PRODUCTS

K-Number: K771365 · 1977-08-16

ApplicantAbbott Laboratories
Decision Date1977-08-16
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CREATININE ANALYSIS PRODUCTS is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1977-08-16 under 510(k) number K771365. 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 ANALYSIS PRODUCTS?

CREATININE ANALYSIS PRODUCTS is a medical device that received FDA 510(k) clearance on 1977-08-16. The listed applicant is Abbott Laboratories. The 510(k) number is K771365.

When did CREATININE ANALYSIS PRODUCTS receive FDA 510(k) clearance?

CREATININE ANALYSIS PRODUCTS received FDA 510(k) clearance on 1977-08-16, under 510(k) number K771365.

Who is the listed applicant for CREATININE ANALYSIS PRODUCTS?

The FDA 510(k) record lists Abbott Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CREATININE ANALYSIS PRODUCTS?

The FDA product code for CREATININE ANALYSIS PRODUCTS is CGX.

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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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