Cleared Traditional

SPR 2 AUTODILUTER

K853380 · Scientific Sales Intl., Inc. · Microbiology
Sep 1985
Decision
31d
Days
Class 1
Risk

About This 510(k) Submission

K853380 is an FDA 510(k) clearance for the SPR 2 AUTODILUTER, a Device, Microtiter Diluting/dispensing (Class I — General Controls, product code JTC), submitted by Scientific Sales Intl., Inc. (Kalamazoo, US). The FDA issued a Cleared decision on September 12, 1985, 31 days after receiving the submission on August 12, 1985. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2500.

Submission Details

510(k) Number K853380 FDA.gov
FDA Decision Cleared SESE
Date Received August 12, 1985
Decision Date September 12, 1985
Days to Decision 31 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JTC — Device, Microtiter Diluting/dispensing
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2500

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