Cleared Traditional

SPORTROL RAPID STERILITY INDICATOR

K962649 · North American Science Assoc., Inc. · General Hospital
Sep 1997
Decision
445d
Days
Class 2
Risk

About This 510(k) Submission

K962649 is an FDA 510(k) clearance for the SPORTROL RAPID STERILITY INDICATOR, a Indicator, Chemical, Enzymatic, Sterilization Process (Class II — Special Controls, product code MTC), submitted by North American Science Assoc., Inc. (Northwood, US). The FDA issued a Cleared decision on September 26, 1997, 445 days after receiving the submission on July 8, 1996. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.

Submission Details

510(k) Number K962649 FDA.gov
FDA Decision Cleared SESE
Date Received July 08, 1996
Decision Date September 26, 1997
Days to Decision 445 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code MTC — Indicator, Chemical, Enzymatic, Sterilization Process
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.2800