CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TEST

Immunoassay Method, Troponin Subunit

PRINCETON BIOMEDITECH CORP.

The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Cardiac Status Ck-mb/myoglobin/troponin I Rapid Test.

Pre-market Notification Details

• Device ID: K981882
• 510k Number: K981882
• Device Name: CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TEST
• Classification: Immunoassay Method, Troponin Subunit
• Applicant: PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 Monmouth Junction, NJ 08852 -1905
• Contact: Jemo Kang
• Correspondent: Jemo Kang; PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 Monmouth Junction, NJ 08852 -1905
• Product Code: MMI
• CFR Regulation Number: 862.1215 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-05-28
• Decision Date: 1998-07-06

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10743816001348	K981882	000
10743816001331	K981882	000
10743816001324	K981882	000