Cleared Traditional

SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334

K992712 · Sigma Diagnostics, Inc. · Hematology
Dec 1999
Decision
117d
Days
Class 2
Risk

About This 510(k) Submission

K992712 is an FDA 510(k) clearance for the SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334, a Activated Partial Thromboplastin (Class II — Special Controls, product code GFO), submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on December 6, 1999, 117 days after receiving the submission on August 11, 1999. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7925.

Submission Details

510(k) Number K992712 FDA.gov
FDA Decision Cleared SESE
Date Received August 11, 1999
Decision Date December 06, 1999
Days to Decision 117 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GFO — Activated Partial Thromboplastin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7925

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