IMMUNOCAP/UNICAP GLIADIN IGA, IMMUNOCAP/UNICAP SPECIFIC IGA, MODELS 14-4425-40, 10-9306-02

Antibodies, Gliadin

PHARMACIA DIAGNOSTICS AB

The following data is part of a premarket notification filed by Pharmacia Diagnostics Ab with the FDA for Immunocap/unicap Gliadin Iga, Immunocap/unicap Specific Iga, Models 14-4425-40, 10-9306-02.

Pre-market Notification Details

• Device ID: K052793
• 510k Number: K052793
• Device Name: IMMUNOCAP/UNICAP GLIADIN IGA, IMMUNOCAP/UNICAP SPECIFIC IGA, MODELS 14-4425-40, 10-9306-02
• Classification: Antibodies, Gliadin
• Applicant: PHARMACIA DIAGNOSTICS AB 4169 COMMERCIAL AVENUE Portage, MI 49002
• Contact: Martin R Mann
• Correspondent: Martin R Mann; PHARMACIA DIAGNOSTICS AB 4169 COMMERCIAL AVENUE Portage, MI 49002
• Product Code: MST
• CFR Regulation Number: 866.5750 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-10-03
• Decision Date: 2006-02-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07333066000510	K052793	000
07333066003764	K052793	000
07333066003740	K052793	000
07333066019574	K052793	000
07333066019550	K052793	000
07333066000732	K052793	000
07333066000725	K052793	000
07333066000718	K052793	000
07333066000701	K052793	000