Cleared Traditional

TURBIDOMETRIC STANDARD

K911059 · Scientific Device Laboratory, Inc. · Microbiology
Jun 1991
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K911059 is an FDA 510(k) clearance for the TURBIDOMETRIC STANDARD, a Reagent/device, Inoculum Calibration (Class II — Special Controls, product code LIE), submitted by Scientific Device Laboratory, Inc. (Glenview, US). The FDA issued a Cleared decision on June 10, 1991, 91 days after receiving the submission on March 11, 1991. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K911059 FDA.gov
FDA Decision Cleared SESE
Date Received March 11, 1991
Decision Date June 10, 1991
Days to Decision 91 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code LIE — Reagent/device, Inoculum Calibration
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.1640