Cleared Traditional

SIMUTANEOUS FIXATION & DECALCIFYING SOLUTION CAL-E

K850636 · Fisher Scientific Co., LLC · Pathology
Mar 1985
Decision
29d
Days
Class 1
Risk

About This 510(k) Submission

K850636 is an FDA 510(k) clearance for the SIMUTANEOUS FIXATION & DECALCIFYING SOLUTION CAL-E, a Solution, Decalcifier, Acid Containing (Class I — General Controls, product code KDX), submitted by Fisher Scientific Co., LLC (Fair Lawn, US). The FDA issued a Cleared decision on March 20, 1985, 29 days after receiving the submission on February 19, 1985. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K850636 FDA.gov
FDA Decision Cleared SESE
Date Received February 19, 1985
Decision Date March 20, 1985
Days to Decision 29 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