Cleared Traditional

DECALCIFYING SOLUTION

K872625 · Stephens Scientific · Pathology
Aug 1987
Decision
31d
Days
Class 1
Risk

About This 510(k) Submission

K872625 is an FDA 510(k) clearance for the DECALCIFYING SOLUTION, a Solution, Decalcifier, Acid Containing (Class I — General Controls, product code KDX), submitted by Stephens Scientific (Denville, US). The FDA issued a Cleared decision on August 6, 1987, 31 days after receiving the submission on July 6, 1987. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K872625 FDA.gov
FDA Decision Cleared SESE
Date Received July 06, 1987
Decision Date August 06, 1987
Days to Decision 31 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