Cleared Traditional

BIOCIRCUITS IOS (IN-OFFICE SYSTEM)

K952719 · Biocircuits Corp. · Chemistry
Nov 1995
Decision
160d
Days
Class 1
Risk

About This 510(k) Submission

K952719 is an FDA 510(k) clearance for the BIOCIRCUITS IOS (IN-OFFICE SYSTEM), a Fluorometer, For Clinical Use (Class I — General Controls, product code KHO), submitted by Biocircuits Corp. (Sunnyvale, US). The FDA issued a Cleared decision on November 22, 1995, 160 days after receiving the submission on June 15, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2560.

Submission Details

510(k) Number K952719 FDA.gov
FDA Decision Cleared SESE
Date Received June 15, 1995
Decision Date November 22, 1995
Days to Decision 160 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code KHO — Fluorometer, For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2560

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