PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2

Immunoassay Method, Troponin Subunit

MITSUBISHI CHEMICAL MEDIENCE CO

The following data is part of a premarket notification filed by Mitsubishi Chemical Medience Co with the FDA for Pathfast Ctni-ii Test, Pathfast Ctni Calibrators, Pathfast Sample Diluent 2.

Pre-market Notification Details

• Device ID: K100130
• 510k Number: K100130
• Device Name: PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2
• Classification: Immunoassay Method, Troponin Subunit
• Applicant: MITSUBISHI CHEMICAL MEDIENCE CO PO BOX 103 Baldwin, MD 21013
• Contact: Judi Smith
• Correspondent: Judi Smith; MITSUBISHI CHEMICAL MEDIENCE CO PO BOX 103 Baldwin, MD 21013
• Product Code: MMI
• CFR Regulation Number: 862.1215 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-01-19
• Decision Date: 2011-05-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04987595301131	K100130	000