MDRWeb Medical Device Register On-line from Canon Communications, LLC

Search for:

510(k) Premarket Notification Database

Device Classification Name:	ENZYMATIC METHOD, TROPONIN SUBUNIT
Regulation Number:	862.1215 [See Other Products with this regulation number]
510(k) Number:	K031739
Device Name:	I-STAT CARDIAC TROPONIN (CTNI) TEST
Applicant:	I-STAT CORPORATION 104 WINDSOR CENTER DR. EAST WINDSOR, NJ 08520
Contact:	GREGORY W SHIPP
Product Code:	MMI [See Other Manufacturers that make this Product]
Date Received:	06-04-2003
Decision Date:	09-02-2003
Decision:	CS
Advisory Committee:	CH
Statement/Summary/Purged Status:	Summary
Type:	Traditional
Review by Third Party:	N
Expedited Review:	N

Canon Communications medical device and pharmaceutical media network includes:
Qmed Medical Device & Diagnostic Industry Medical Product & Manufacturing News European Medical Device Technology China Medical Device Manufacturer In Vitro Diagnostic Technology	Med Ad News R&D Directions PharmaLive.com Pharmalot.com eKnowledgebase Pharmaceutical & Medical Packaging News Packaging Digest