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FDA 510(k)

IN-VITRO TEST DETERMINATION OF ALBUMIN

K-Number: K854181 · 1985-11-25

ApplicantClinical Data, Inc.
Decision Date1985-11-25
Product CodeCIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IN-VITRO TEST DETERMINATION OF ALBUMIN is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Data, Inc.. It received FDA 510(k) clearance on 1985-11-25 under 510(k) number K854181. 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 IN-VITRO TEST DETERMINATION OF ALBUMIN?

IN-VITRO TEST DETERMINATION OF ALBUMIN is a medical device that received FDA 510(k) clearance on 1985-11-25. The listed applicant is Clinical Data, Inc.. The 510(k) number is K854181.

When did IN-VITRO TEST DETERMINATION OF ALBUMIN receive FDA 510(k) clearance?

IN-VITRO TEST DETERMINATION OF ALBUMIN received FDA 510(k) clearance on 1985-11-25, under 510(k) number K854181.

Who is the listed applicant for IN-VITRO TEST DETERMINATION OF ALBUMIN?

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

What is the FDA product code for IN-VITRO TEST DETERMINATION OF ALBUMIN?

The FDA product code for IN-VITRO TEST DETERMINATION OF ALBUMIN 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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