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FDA 510(k)

A-GENT ALBUMIN

K-Number: K770822 · 1977-07-11

ApplicantAbbott Laboratories
Decision Date1977-07-11
Product CodeCIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

A-GENT ALBUMIN is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1977-07-11 under 510(k) number K770822. The device is classified under product code CIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A-GENT ALBUMIN?

A-GENT ALBUMIN is a medical device that received FDA 510(k) clearance on 1977-07-11. The listed applicant is Abbott Laboratories. The 510(k) number is K770822.

When did A-GENT ALBUMIN receive FDA 510(k) clearance?

A-GENT ALBUMIN received FDA 510(k) clearance on 1977-07-11, under 510(k) number K770822.

Who is the listed applicant for A-GENT ALBUMIN?

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 A-GENT ALBUMIN?

The FDA product code for A-GENT ALBUMIN is CIX.

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Related Devices (Code: CIX)

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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