EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT

Bromcresol Green Dye-binding, Albumin

MEDICA CORP.

The following data is part of a premarket notification filed by Medica Corp. with the FDA for Easyra Alb Reagent And Easyra Alp Reagent, Model 10218/10214, Easyra Ast Reagent, Model 10206, Easyra Co2 Reagent.

Pre-market Notification Details

• Device ID: K080874
• 510k Number: K080874
• Device Name: EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT
• Classification: Bromcresol Green Dye-binding, Albumin
• 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: CIX
• Subsequent Product Code: CGS
• Subsequent Product Code: CIT
• Subsequent Product Code: CJE
• Subsequent Product Code: JFY
• Subsequent Product Code: JIT
• Subsequent Product Code: KHS
• CFR Regulation Number: 862.1035 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-03-31
• Decision Date: 2009-02-20

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00386100002183	K080874	000
00386100002145	K080874	000
00386100002107	K080874	000
00386100002053	K080874	000
00386100002022	K080874	000
00386100001995	K080874	000