Cleared Traditional

K851399 - BAC-T-SCREEN
(FDA 510(k) Clearance)

K851399 · Marion Laboratories, Inc. · Microbiology

Jun 1985

Decision

56d

Days

Class 1

Risk

K851399 is an FDA 510(k) clearance for the BAC-T-SCREEN, a Kit, Screening, Urine (Class I — General Controls, product code JXA), submitted by Marion Laboratories, Inc. (Kansas City, US). The FDA issued a Cleared decision on June 4, 1985, 56 days after receiving the submission on April 9, 1985. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number	K851399 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 09, 1985
Decision Date	June 04, 1985
Days to Decision	56 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—