Cleared Traditional

MYREADER 7

K853284 · Scientific Sales Intl., Inc. · Microbiology
Oct 1985
Decision
60d
Days
Class 1
Risk

About This 510(k) Submission

K853284 is an FDA 510(k) clearance for the MYREADER 7, a Colorimeter, Photometer, Spectrophotometer For Clinical Use (Class I — General Controls, product code JJQ), submitted by Scientific Sales Intl., Inc. (Kalamazoo, US). The FDA issued a Cleared decision on October 4, 1985, 60 days after receiving the submission on August 5, 1985. This device falls under the Microbiology review panel. Regulated under 21 CFR 862.2300.

Submission Details

510(k) Number K853284 FDA.gov
FDA Decision Cleared SESE
Date Received August 05, 1985
Decision Date October 04, 1985
Days to Decision 60 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JJQ — Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2300

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