Cleared Traditional

IMMUNOADSORBED FACTOR X DEFICIENT PLASMA (HUMAN)

K870353 · American Dade · Hematology
Feb 1987
Decision
12d
Days
Class 2
Risk

About This 510(k) Submission

K870353 is an FDA 510(k) clearance for the IMMUNOADSORBED FACTOR X DEFICIENT PLASMA (HUMAN), a Test, Qualitative And Quantitative Factor Deficiency (Class II — Special Controls, product code GGP), submitted by American Dade (Santa Ana, US). The FDA issued a Cleared decision on February 10, 1987, 12 days after receiving the submission on January 29, 1987. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number K870353 FDA.gov
FDA Decision Cleared SESE
Date Received January 29, 1987
Decision Date February 10, 1987
Days to Decision 12 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GGP — Test, Qualitative And Quantitative Factor Deficiency
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7290

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