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FDA 510(k)

ALBUMIN IN SERUM

K-Number: K873862 · 1987-10-20

ApplicantUnipath , Ltd.
Decision Date1987-10-20
Product CodeDCF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ALBUMIN IN SERUM is the device name listed in this FDA 510(k) record. The listed applicant is Unipath , Ltd.. It received FDA 510(k) clearance on 1987-10-20 under 510(k) number K873862. The device is classified under product code DCF. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALBUMIN IN SERUM?

ALBUMIN IN SERUM is a medical device that received FDA 510(k) clearance on 1987-10-20. The listed applicant is Unipath , Ltd.. The 510(k) number is K873862.

When did ALBUMIN IN SERUM receive FDA 510(k) clearance?

ALBUMIN IN SERUM received FDA 510(k) clearance on 1987-10-20, under 510(k) number K873862.

Who is the listed applicant for ALBUMIN IN SERUM?

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

What is the FDA product code for ALBUMIN IN SERUM?

The FDA product code for ALBUMIN IN SERUM is DCF.

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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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