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FDA 510(k)

IMMUNOADSORBED FACTOR V DEFICIENT PLASMA (HUMAN)

K-Number: K870354 · 1987-02-10

ApplicantAmerican Dade
Decision Date1987-02-10
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

IMMUNOADSORBED FACTOR V DEFICIENT PLASMA (HUMAN) is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1987-02-10 under 510(k) number K870354. The device is classified under product code GGP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUNOADSORBED FACTOR V DEFICIENT PLASMA (HUMAN)?

IMMUNOADSORBED FACTOR V DEFICIENT PLASMA (HUMAN) is a medical device that received FDA 510(k) clearance on 1987-02-10. The listed applicant is American Dade. The 510(k) number is K870354.

When did IMMUNOADSORBED FACTOR V DEFICIENT PLASMA (HUMAN) receive FDA 510(k) clearance?

IMMUNOADSORBED FACTOR V DEFICIENT PLASMA (HUMAN) received FDA 510(k) clearance on 1987-02-10, under 510(k) number K870354.

Who is the listed applicant for IMMUNOADSORBED FACTOR V DEFICIENT PLASMA (HUMAN)?

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

What is the FDA product code for IMMUNOADSORBED FACTOR V DEFICIENT PLASMA (HUMAN)?

The FDA product code for IMMUNOADSORBED FACTOR V DEFICIENT PLASMA (HUMAN) is GGP.

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Related Devices (Code: GGP)

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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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