Cleared Traditional

MR7000 WITH TIME MANAGER SOFTWARE (TMS)

K934111 · Dynatech Laboratories, Inc. · Microbiology
Nov 1994
Decision
456d
Days
Class 1
Risk

About This 510(k) Submission

K934111 is an FDA 510(k) clearance for the MR7000 WITH TIME MANAGER SOFTWARE (TMS), a Calculator/data Processing Module, For Clinical Use (Class I — General Controls, product code JQP), submitted by Dynatech Laboratories, Inc. (Chantilly, US). The FDA issued a Cleared decision on November 2, 1994, 456 days after receiving the submission on August 3, 1993. This device falls under the Microbiology review panel. Regulated under 21 CFR 862.2100.

Submission Details

510(k) Number K934111 FDA.gov
FDA Decision Cleared SESE
Date Received August 03, 1993
Decision Date November 02, 1994
Days to Decision 456 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code JQP — Calculator/data Processing Module, For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2100

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