Cleared Traditional

K830526 - B-GCG SYSTEM BY RIA
(FDA 510(k) Clearance)

K830526 · Pcl-Ria, Inc. · Chemistry
Apr 1983
Decision
47d
Days
Class 2
Risk

K830526 is an FDA 510(k) clearance for the B-GCG SYSTEM BY RIA. This device is classified as a Visual, Pregnancy Hcg, Prescription Use (Class II — Special Controls, product code JHI).

Submitted by Pcl-Ria, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 5, 1983, 47 days after receiving the submission on February 17, 1983.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K830526 FDA.gov
FDA Decision Cleared SESE
Date Received February 17, 1983
Decision Date April 05, 1983
Days to Decision 47 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JHI — Visual, Pregnancy Hcg, Prescription Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1155

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