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FDA 510(k)

ALBUMIN TEST, HMA ALBUMIN TEST

K-Number: K771259 · 1977-08-22

ApplicantHycel, Inc.
Decision Date1977-08-22
Product CodeCIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALBUMIN TEST, HMA ALBUMIN TEST is the device name listed in this FDA 510(k) record. The listed applicant is Hycel, Inc.. It received FDA 510(k) clearance on 1977-08-22 under 510(k) number K771259. 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 TEST, HMA ALBUMIN TEST?

ALBUMIN TEST, HMA ALBUMIN TEST is a medical device that received FDA 510(k) clearance on 1977-08-22. The listed applicant is Hycel, Inc.. The 510(k) number is K771259.

When did ALBUMIN TEST, HMA ALBUMIN TEST receive FDA 510(k) clearance?

ALBUMIN TEST, HMA ALBUMIN TEST received FDA 510(k) clearance on 1977-08-22, under 510(k) number K771259.

Who is the listed applicant for ALBUMIN TEST, HMA ALBUMIN TEST?

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

What is the FDA product code for ALBUMIN TEST, HMA ALBUMIN TEST?

The FDA product code for ALBUMIN TEST, HMA ALBUMIN TEST is CIX.

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Other records listing Hycel, Inc. as applicant

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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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