Cleared Traditional

TURBIQUANT ASL

K915742 · Behring Diagnostics, Inc. · Microbiology
Jun 1993
Decision
553d
Days
Class 1
Risk

About This 510(k) Submission

K915742 is an FDA 510(k) clearance for the TURBIQUANT ASL, a Antistreptolysin - Titer/streptolysin O Reagent (Class I — General Controls, product code GTQ), submitted by Behring Diagnostics, Inc. (Somerville, US). The FDA issued a Cleared decision on June 28, 1993, 553 days after receiving the submission on December 23, 1991. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3720.

Submission Details

510(k) Number K915742 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 1991
Decision Date June 28, 1993
Days to Decision 553 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code GTQ — Antistreptolysin - Titer/streptolysin O Reagent
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3720

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