Cleared Traditional

PASCO GRAM NEGATIVE IDENTIFICATION SYSTEM

K851528 · Pasco Laboratories, Inc. · Microbiology
Jul 1985
Decision
88d
Days
Class 1
Risk

About This 510(k) Submission

K851528 is an FDA 510(k) clearance for the PASCO GRAM NEGATIVE IDENTIFICATION SYSTEM, a Gram Negative Identification Panel (Class I — General Controls, product code LQM), submitted by Pasco Laboratories, Inc. (Wheat Ridge, US). The FDA issued a Cleared decision on July 15, 1985, 88 days after receiving the submission on April 18, 1985. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K851528 FDA.gov
FDA Decision Cleared SESE
Date Received April 18, 1985
Decision Date July 15, 1985
Days to Decision 88 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code LQM — Gram Negative Identification Panel
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660

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