Cleared Traditional

ANTITHROMBIN III SCREEN KIT

K812215 · Pacific Hemostasis · Hematology
Sep 1981
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K812215 is an FDA 510(k) clearance for the ANTITHROMBIN III SCREEN KIT, a Antithrombin Iii Quantitation (Class II — Special Controls, product code JBQ), submitted by Pacific Hemostasis (Mchenry, US). The FDA issued a Cleared decision on September 1, 1981, 27 days after receiving the submission on August 5, 1981. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7060.

Submission Details

510(k) Number K812215 FDA.gov
FDA Decision Cleared SESE
Date Received August 05, 1981
Decision Date September 01, 1981
Days to Decision 27 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code JBQ — Antithrombin Iii Quantitation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7060

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