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FDA 510(k)

DADE FACTOR ASSAY REFERENCE PLASMA

K-Number: K820085 · 1982-02-23

ApplicantAmerican Dade
Decision Date1982-02-23
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DADE FACTOR ASSAY REFERENCE PLASMA is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1982-02-23 under 510(k) number K820085. 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 DADE FACTOR ASSAY REFERENCE PLASMA?

DADE FACTOR ASSAY REFERENCE PLASMA is a medical device that received FDA 510(k) clearance on 1982-02-23. The listed applicant is American Dade. The 510(k) number is K820085.

When did DADE FACTOR ASSAY REFERENCE PLASMA receive FDA 510(k) clearance?

DADE FACTOR ASSAY REFERENCE PLASMA received FDA 510(k) clearance on 1982-02-23, under 510(k) number K820085.

Who is the listed applicant for DADE FACTOR ASSAY REFERENCE PLASMA?

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 DADE FACTOR ASSAY REFERENCE PLASMA?

The FDA product code for DADE FACTOR ASSAY REFERENCE PLASMA is 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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