Cleared Traditional

IMMUNO/ASO

K894780 · Immunostics Co., Inc. · Microbiology
Oct 1989
Decision
81d
Days
Class 1
Risk

About This 510(k) Submission

K894780 is an FDA 510(k) clearance for the IMMUNO/ASO, a Antistreptolysin - Titer/streptolysin O Reagent (Class I — General Controls, product code GTQ), submitted by Immunostics Co., Inc. (Ocean, US). The FDA issued a Cleared decision on October 16, 1989, 81 days after receiving the submission on July 27, 1989. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3720.

Submission Details

510(k) Number K894780 FDA.gov
FDA Decision Cleared SESE
Date Received July 27, 1989
Decision Date October 16, 1989
Days to Decision 81 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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