Cleared Traditional

ANABAG

K871238 · Scott Laboratories, Inc. · Microbiology
Apr 1987
Decision
7d
Days
Class 1
Risk

About This 510(k) Submission

K871238 is an FDA 510(k) clearance for the ANABAG, a Device, Gas Generating (Class I — General Controls, product code KZJ), submitted by Scott Laboratories, Inc. (Fiskeville, US). The FDA issued a Cleared decision on April 3, 1987, 7 days after receiving the submission on March 27, 1987. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2580.

Submission Details

510(k) Number K871238 FDA.gov
FDA Decision Cleared SESE
Date Received March 27, 1987
Decision Date April 03, 1987
Days to Decision 7 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code KZJ — Device, Gas Generating
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2580

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