TC MATRIX CLINICAL CHEMISTRY ANALYZER

Analyzer, Chemistry (photometric, Discrete), For Clinical Use

TECO DIAGNOSTICS

The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for Tc Matrix Clinical Chemistry Analyzer.

Pre-market Notification Details

• Device ID: K073370
• 510k Number: K073370
• Device Name: TC MATRIX CLINICAL CHEMISTRY ANALYZER
• Classification: Analyzer, Chemistry (photometric, Discrete), For Clinical Use
• Applicant: TECO DIAGNOSTICS 1268 NORTH LAKEVIEW AVE. Anaheim, CA 92807
• Contact: Jim Vaechhes
• Correspondent: Jim Vaechhes; TECO DIAGNOSTICS 1268 NORTH LAKEVIEW AVE. Anaheim, CA 92807
• Product Code: JJE
• Subsequent Product Code: CDQ
• Subsequent Product Code: CGA
• Subsequent Product Code: CIX
• Subsequent Product Code: CKA
• Subsequent Product Code: JIX
• CFR Regulation Number: 862.2160 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-11-30
• Decision Date: 2008-05-08

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10673486013962	K073370	000
10673486013894	K073370	000
10673486013726	K073370	000
10673486013580	K073370	000