Cleared Traditional

ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42

K881879 · Alpha-Tec Systems, Inc. · Pathology
May 1988
Decision
9d
Days
Class 1
Risk

About This 510(k) Submission

K881879 is an FDA 510(k) clearance for the ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42, 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 13, 1988, 9 days after receiving the submission on May 4, 1988. This device falls under the Pathology review panel. Regulated under 21 CFR 866.2450.

Submission Details

510(k) Number K881879 FDA.gov
FDA Decision Cleared SESE
Date Received May 04, 1988
Decision Date May 13, 1988
Days to Decision 9 days
Submission Type Traditional
Review Panel Pathology (PA)
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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