Cleared Traditional

QM300 CONTROL G PACK

K910887 · Kallestad Diag, A Div. of Erbamont, Inc. · Microbiology
Jun 1991
Decision
105d
Days
Class 1
Risk

About This 510(k) Submission

K910887 is an FDA 510(k) clearance for the QM300 CONTROL G PACK, a Antistreptolysin - Titer/streptolysin O Reagent (Class I — General Controls, product code GTQ), submitted by Kallestad Diag, A Div. of Erbamont, Inc. (Chaska, US). The FDA issued a Cleared decision on June 17, 1991, 105 days after receiving the submission on March 4, 1991. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3720.

Submission Details

510(k) Number K910887 FDA.gov
FDA Decision Cleared SESE
Date Received March 04, 1991
Decision Date June 17, 1991
Days to Decision 105 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

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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