Cleared Traditional

PERMACLEAR SOLUTION CAT. NO. 4950

K861490 · Helena Laboratories · Pathology
May 1986
Decision
14d
Days
Class 1
Risk

About This 510(k) Submission

K861490 is an FDA 510(k) clearance for the PERMACLEAR SOLUTION CAT. NO. 4950, a Agent, Clearing (Class I — General Controls, product code KEM), submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on May 6, 1986, 14 days after receiving the submission on April 22, 1986. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K861490 FDA.gov
FDA Decision Cleared SESE
Date Received April 22, 1986
Decision Date May 06, 1986
Days to Decision 14 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code KEM — Agent, Clearing
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.4010