THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY CONTROL, MODEL, CHA, CHU, M5155, M5158

Multi-analyte Controls, All Kinds (assayed)

MICROGENICS CORP.

The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Thermo Scientific Mas Chem Trak & Moni Trol H Liquid Assayed Chemistry Control, Model, Cha, Chu, M5155, M5158.

Pre-market Notification Details

• Device ID: K092051
• 510k Number: K092051
• Device Name: THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY CONTROL, MODEL, CHA, CHU, M5155, M5158
• Classification: Multi-analyte Controls, All Kinds (assayed)
• Applicant: MICROGENICS CORP. 46360 FREMONT BLVD Fremont, CA 94538
• Contact: Lisa Charter
• Correspondent: Lisa Charter; MICROGENICS CORP. 46360 FREMONT BLVD Fremont, CA 94538
• Product Code: JJY
• CFR Regulation Number: 862.1660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-07-07
• Decision Date: 2009-09-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00884883004207	K092051	000
00884883003736	K092051	000
00884883003743	K092051	000
00884883003750	K092051	000
00884883003767	K092051	000
00884883003774	K092051	000
00884883003781	K092051	000
00884883003798	K092051	000
00884883004184	K092051	000
00884883004191	K092051	000
00884883003729	K092051	000