Cleared Traditional

ACTIN FSL ACTIVATED PTT REAGENT

K863594 · American Dade · Hematology
Oct 1986
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K863594 is an FDA 510(k) clearance for the ACTIN FSL ACTIVATED PTT REAGENT, a Test, Time, Partial Thromboplastin (Class II — Special Controls, product code GGW), submitted by American Dade (Santa Ana, US). The FDA issued a Cleared decision on October 17, 1986, 32 days after receiving the submission on September 15, 1986. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7925.

Submission Details

510(k) Number K863594 FDA.gov
FDA Decision Cleared SESE
Date Received September 15, 1986
Decision Date October 17, 1986
Days to Decision 32 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GGW — Test, Time, Partial Thromboplastin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7925

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