Cleared Traditional

CHALLENGE TEST PACK

K983451 · North American Science Assoc., Inc. · General Hospital
Apr 1999
Decision
205d
Days
Class 2
Risk

About This 510(k) Submission

K983451 is an FDA 510(k) clearance for the CHALLENGE TEST PACK, a Indicator, Physical/chemical Sterilization Process (Class II — Special Controls, product code JOJ), submitted by North American Science Assoc., Inc. (Northwood, US). The FDA issued a Cleared decision on April 23, 1999, 205 days after receiving the submission on September 30, 1998. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.

Submission Details

510(k) Number K983451 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 1998
Decision Date April 23, 1999
Days to Decision 205 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code JOJ — Indicator, Physical/chemical Sterilization Process
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.2800

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