Cleared Traditional

OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT

K953437 · Olympus America, Inc. · Microbiology
Oct 1995
Decision
91d
Days
Class 1
Risk

About This 510(k) Submission

K953437 is an FDA 510(k) clearance for the OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT, a Antistreptolysin - Titer/streptolysin O Reagent (Class I — General Controls, product code GTQ), submitted by Olympus America, Inc. (Melville, US). The FDA issued a Cleared decision on October 20, 1995, 91 days after receiving the submission on July 21, 1995. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3720.

Submission Details

510(k) Number K953437 FDA.gov
FDA Decision Cleared SESE
Date Received July 21, 1995
Decision Date October 20, 1995
Days to Decision 91 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

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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