Cleared Traditional

DECALCIFIER II

K810836 · Surgipath · Pathology
Apr 1981
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K810836 is an FDA 510(k) clearance for the DECALCIFIER II, a Solution, Decalcifier, Acid Containing (Class I — General Controls, product code KDX), submitted by Surgipath (Mchenry, US). The FDA issued a Cleared decision on April 23, 1981, 28 days after receiving the submission on March 26, 1981. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K810836 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 1981
Decision Date April 23, 1981
Days to Decision 28 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code KDX — Solution, Decalcifier, Acid Containing
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.4010