Cleared Traditional

ATS NAC-PAC SET

K881949 · Alpha-Tec Systems, Inc. · Microbiology
May 1988
Decision
15d
Days
Class 1
Risk

About This 510(k) Submission

K881949 is an FDA 510(k) clearance for the ATS NAC-PAC SET, a Supplement, Culture Media (Class I — General Controls, product code JSK), submitted by Alpha-Tec Systems, Inc. (Irvine, US). The FDA issued a Cleared decision on May 25, 1988, 15 days after receiving the submission on May 10, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2450.

Submission Details

510(k) Number K881949 FDA.gov
FDA Decision Cleared SESE
Date Received May 10, 1988
Decision Date May 25, 1988
Days to Decision 15 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JSK — Supplement, Culture Media
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2450

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