Medical Device Manufacturer · US , Tustin , CA

Micro Detect, Inc.

11 submissions · 11 cleared · Since 1998
11
Total
11
Cleared
0
Denied

Micro Detect, Inc. — FDA 510(k) Submissions

Micro Detect, Inc. has submitted 11 FDA 510(k) premarket notifications since 1998, of which 11 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Antinuclear Antibody (enzyme-labeled), Antigen, Controls, Extractable Antinuclear Antibody, Antigen And Control, Antibodies, Gliadin, Helicobacter Pylori, System, Test, Rheumatoid Factor . Use the specialty filter in the sidebar to narrow results.

11 devices
1–11 of 11
ELISA TEST, SEROLOGY
K003794 · LYR Helicobacter Pylori · Microbiology
Mar 2001 112d
MDI GLIADIN A TEST
K002358 · MST Antibodies, Gliadin · Immunology
Oct 2000 78d
MDI GLIADIN G TEST
K002359 · MST Antibodies, Gliadin · Immunology
Oct 2000 78d
MDI SCL-70 TEST
K000934 · LJM Antinuclear Antibody... · Immunology
Apr 2000 15d
MDI DS-DNA TEST
K000477 · LRM Anti-dna Antibody... · Immunology
Mar 2000 16d
MDI RF TEST
K993843 · DHR System, Test, Rheumatoid... · Immunology
Jan 2000 60d
MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOANTIBODIES TO SS-B IN HUMAN SERUM
K993971 · LLL Extractable Antinuclear... · Immunology
Jan 2000 49d
MDI SM TEST
K994029 · LLL Extractable Antinuclear... · Immunology
Jan 2000 46d
MDI SM/RNP TEST
K993635 · LJM Antinuclear Antibody... · Immunology
Jan 2000 75d
MDI SS-A TEST
K993636 · LJM Antinuclear Antibody... · Immunology
Jan 2000 75d
PYLORI DETECT IGG
K973508 · LYR Helicobacter Pylori · Microbiology
Mar 1998 175d
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