Cleared Traditional

ATS CRYPTOSPORIDIUM STAIN CONTROL SLIDES

K880962 · Alpha-Tec Systems, Inc. · Microbiology
Mar 1988
Decision
22d
Days
Class 1
Risk

About This 510(k) Submission

K880962 is an FDA 510(k) clearance for the ATS CRYPTOSPORIDIUM STAIN CONTROL SLIDES, a Quality Control Slides (Class I — General Controls, product code LJG), submitted by Alpha-Tec Systems, Inc. (Irvine, US). The FDA issued a Cleared decision on March 30, 1988, 22 days after receiving the submission on March 8, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K880962 FDA.gov
FDA Decision Cleared SESE
Date Received March 08, 1988
Decision Date March 30, 1988
Days to Decision 22 days
Submission Type Traditional
Review Panel Microbiology (MI)
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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