Cleared Traditional

RAPID AS LATEX

K862530 · Dilab, Inc. · Microbiology
Apr 1987
Decision
293d
Days
Class 1
Risk

About This 510(k) Submission

K862530 is an FDA 510(k) clearance for the RAPID AS LATEX, a Antistreptolysin - Titer/streptolysin O Reagent (Class I — General Controls, product code GTQ), submitted by Dilab, Inc. (Miami, US). The FDA issued a Cleared decision on April 21, 1987, 293 days after receiving the submission on July 2, 1986. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3720.

Submission Details

510(k) Number K862530 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 1986
Decision Date April 21, 1987
Days to Decision 293 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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