Cleared Traditional

BAC-T-SCREEN BACTERIURIA DETECTION DEV

K823850 · Marion Laboratories, Inc. · Microbiology
Mar 1983
Decision
70d
Days
Class 1
Risk

About This 510(k) Submission

K823850 is an FDA 510(k) clearance for the BAC-T-SCREEN BACTERIURIA DETECTION DEV, a Kit, Screening, Urine (Class I — General Controls, product code JXA), submitted by Marion Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on March 1, 1983, 70 days after receiving the submission on December 21, 1982. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K823850 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 1982
Decision Date March 01, 1983
Days to Decision 70 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JXA — Kit, Screening, Urine
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660

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