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FDA 510(k)

ALBUMIN PROCEDURE, TEKPOINT BROMCRESOL

K-Number: K770451 · 1977-05-03

ApplicantIcn Pharmaceuticals, Inc.
Decision Date1977-05-03
Product CodeCIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALBUMIN PROCEDURE, TEKPOINT BROMCRESOL is the device name listed in this FDA 510(k) record. The listed applicant is Icn Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 1977-05-03 under 510(k) number K770451. 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 ALBUMIN PROCEDURE, TEKPOINT BROMCRESOL?

ALBUMIN PROCEDURE, TEKPOINT BROMCRESOL is a medical device that received FDA 510(k) clearance on 1977-05-03. The listed applicant is Icn Pharmaceuticals, Inc.. The 510(k) number is K770451.

When did ALBUMIN PROCEDURE, TEKPOINT BROMCRESOL receive FDA 510(k) clearance?

ALBUMIN PROCEDURE, TEKPOINT BROMCRESOL received FDA 510(k) clearance on 1977-05-03, under 510(k) number K770451.

Who is the listed applicant for ALBUMIN PROCEDURE, TEKPOINT BROMCRESOL?

The FDA 510(k) record lists Icn Pharmaceuticals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALBUMIN PROCEDURE, TEKPOINT BROMCRESOL?

The FDA product code for ALBUMIN PROCEDURE, TEKPOINT BROMCRESOL is CIX.

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Related Devices (Code: CIX)

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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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