Medical Device Manufacturer · US , Carlsbad , CA

Ivd Research, Inc.

5 submissions · 5 cleared · Since 2002

Total

Cleared

Denied

Ivd Research, Inc. — FDA 510(k) Submissions

Ivd Research, Inc. has submitted 5 FDA 510(k) premarket notifications since 2002, of which 5 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Giardia Spp., Cryptosporidium Spp., Reagents, Clostridium Difficile Toxin . Use the specialty filter in the sidebar to narrow results.

5 devices

1–5 of 5

GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF

K081064 · MHI Giardia Spp. · Microbiology

Jan 2009 275d

C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL; CDIFF-96

K032897 · LLH Reagents, Clostridium... · Microbiology

May 2004 253d

IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96

K031059 · MHJ Cryptosporidium Spp. · Microbiology

Jul 2003 104d

IVD CRYPTO/GIARDIA DFA