EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTES

System, Test, Low Density, Lipoprotein

MEDICA CORP.

The following data is part of a premarket notification filed by Medica Corp. with the FDA for Easyra Dldl Reagent, Calibrator; Easyqc Chemistry No Electrolytes, With Electrolytes.

Pre-market Notification Details

• Device ID: K090734
• 510k Number: K090734
• Device Name: EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTES
• Classification: System, Test, Low Density, Lipoprotein
• Applicant: MEDICA CORP. 5 OAK PARK DRIVE Bedford, MA 01730
• Contact: Photios Makris
• Correspondent: Photios Makris; MEDICA CORP. 5 OAK PARK DRIVE Bedford, MA 01730
• Product Code: MRR
• Subsequent Product Code: JIX
• Subsequent Product Code: JJY
• CFR Regulation Number: 862.1475 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-03-19
• Decision Date: 2009-07-17

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00386100002206	K090734	000
00386100001766	K090734	000