Cleared Traditional

MEDTEC AUTOBLOT 2000

K951753 · Medtec, Inc. · Microbiology
Oct 1995
Decision
183d
Days
Class 1
Risk

About This 510(k) Submission

K951753 is an FDA 510(k) clearance for the MEDTEC AUTOBLOT 2000, a Station, Pipetting And Diluting, For Clinical Use (Class I — General Controls, product code JQW), submitted by Medtec, Inc. (Washington, US). The FDA issued a Cleared decision on October 17, 1995, 183 days after receiving the submission on April 17, 1995. This device falls under the Microbiology review panel. Regulated under 21 CFR 862.2750.

Submission Details

510(k) Number K951753 FDA.gov
FDA Decision Cleared SESE
Date Received April 17, 1995
Decision Date October 17, 1995
Days to Decision 183 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code JQW — Station, Pipetting And Diluting, For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2750

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