Cleared Traditional

ATS CRYPTOSPORIDIUM STAIN SET

K880989 · Alpha-Tec Systems, Inc. · Pathology
May 1988
Decision
66d
Days
Class 1
Risk

About This 510(k) Submission

K880989 is an FDA 510(k) clearance for the ATS CRYPTOSPORIDIUM STAIN SET, a Stains, Microbiologic (Class I — General Controls, product code JTS), submitted by Alpha-Tec Systems, Inc. (Irvine, US). The FDA issued a Cleared decision on May 13, 1988, 66 days after receiving the submission on March 8, 1988. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K880989 FDA.gov
FDA Decision Cleared SESE
Date Received March 08, 1988
Decision Date May 13, 1988
Days to Decision 66 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code JTS — Stains, Microbiologic
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.1850