CHALLENGE TEST PACK— 510(k) K983451

Name: FDA 510(k) clearance K983451
Creator: U.S. Food and Drug Administration
Published: 1999-04-23

Substantially Equivalent

North American Science Assoc., Inc.

FDA 510(k) clearance K983451 for CHALLENGE TEST PACK, Substantially Equivalent on 1999-04-23. Applicant: North American Science Assoc., Inc.. Device class: 2.

Clearance details

Applicant: North American Science Assoc., Inc.
Product code: Product code JOJ
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 1998-09-30
Decision date: 1999-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northwood, OH, US

Download summary PDF View on FDA.gov ↗

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