Cleared Traditional

BIOGLAS MICROCARRIER BEAD

K852506 · Solohill Engineering, Inc. · Pathology
Jul 1985
Decision
30d
Days
Class 1
Risk

About This 510(k) Submission

K852506 is an FDA 510(k) clearance for the BIOGLAS MICROCARRIER BEAD, a Apparatus, Roller (Class I — General Controls, product code KJB), submitted by Solohill Engineering, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on July 12, 1985, 30 days after receiving the submission on June 12, 1985. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2240.

Submission Details

510(k) Number K852506 FDA.gov
FDA Decision Cleared SESE
Date Received June 12, 1985
Decision Date July 12, 1985
Days to Decision 30 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code KJB — Apparatus, Roller
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.2240