Cleared Traditional

ATS PARASITOLOGY STAIN CONTROL SLIDE

K823705 · Alpha-Tec Systems, Inc. · Hematology
Jan 1983
Decision
29d
Days
Class 1
Risk

About This 510(k) Submission

K823705 is an FDA 510(k) clearance for the ATS PARASITOLOGY STAIN CONTROL SLIDE, a Quality Control Slides (Class I — General Controls, product code LJG), submitted by Alpha-Tec Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 7, 1983, 29 days after receiving the submission on December 9, 1982. This device falls under the Hematology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K823705 FDA.gov
FDA Decision Cleared SESE
Date Received December 09, 1982
Decision Date January 07, 1983
Days to Decision 29 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code LJG — Quality Control Slides
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660

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