Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Immco Diagnostics, Inc. — Predicate Candidate Screening
55 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
186 daysmedian FDA review time
409 days90th percentile
55clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K172745 | ImmuGlo HEp-2 Elite IFA | Immco Diagnostics, Inc. | 2018-06-05 | 266 | 0 |
| K172078 | ImmuLisa Enhanced RNA POL III Antibody ELISA | Immco Diagnostics, Inc. | 2018-03-30 | 263 | 0 |
| K163133 | ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced | Immco Diagnostics, Inc. | 2017-08-08 | 273 | 0 |
| K163177 | ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhan | Immco Diagnostics, Inc. | 2017-07-28 | 256 | 0 |
| K162788 | ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhance | Immco Diagnostics, Inc. | 2017-06-19 | 259 | 0 |
| K151559 | ImmuLisa Enhanced Centromere Antibody ELISA | Immco Diagnostics, Inc. | 2016-03-11 | 275 | 0 |
| K143736 | ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced R | Immco Diagnostics, Inc. | 2015-09-23 | 267 | 0 |
| K142781 | ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhance | Immco Diagnostics, Inc. | 2015-03-31 | 186 | 0 |
| K123713 | IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY E | Immco Diagnostics, Inc. | 2013-10-25 | 325 | 0 |
| K113020 | IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG | Immco Diagnostics, Inc. | 2012-10-25 | 380 | 0 |
| K113143 | IMMULISA SCI-70 ANTIBODY ELISA | Immco Diagnostics, Inc. | 2011-12-02 | 38 | 0 |
| K101319 | IMMULISA DSDNA ANTIBODY ELISA | Immco Diagnostics, Inc. | 2010-12-09 | 212 | 0 |
| K092600 | IMMULISA PR3 ANTIBODY ELISA | Immco Diagnostics, Inc. | 2010-10-07 | 409 | 0 |
| K092601 | IMMULISA ANCA SCREEN ELISA | Immco Diagnostics, Inc. | 2010-10-07 | 409 | 0 |
| K092599 | IMMULISA MPO ANTIBODY ELISA | Immco Diagnostics, Inc. | 2010-10-07 | 409 | 0 |
| K091520 | IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA | Immco Diagnostics, Inc. | 2010-03-10 | 292 | 0 |
| K091522 | IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA | Immco Diagnostics, Inc. | 2010-02-04 | 258 | 0 |
| K071346 | IMMULISA INTRINSIC FACTOR ANTIBODY ELISA | Immco Diagnostics, Inc. | 2007-09-24 | 133 | 0 |
| K060157 | IMMUGLO ANTI-ENDOMYSIAL ANTIBODY IFA | Immco Diagnostics, Inc. | 2006-05-25 | 125 | 0 |
| K041102 | IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA | Immco Diagnostics, Inc. | 2004-10-26 | 182 | 0 |
| K032860 | IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA) | Immco Diagnostics, Inc. | 2004-03-18 | 188 | 0 |
| K032850 | IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG) | Immco Diagnostics, Inc. | 2004-03-18 | 188 | 0 |
| K040095 | IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBOD | Immco Diagnostics, Inc. | 2004-03-05 | 45 | 0 |
| K032571 | IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBOD | Immco Diagnostics, Inc. | 2003-12-24 | 126 | 0 |
| K030701 | IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGG ELISA | Immco Diagnostics, Inc. | 2003-09-09 | 187 | 0 |
| K030702 | IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA | Immco Diagnostics, Inc. | 2003-09-09 | 187 | 0 |
| K992878 | ANTI-TISSUE TRANSGLUTAMINASE (TTG)ANTIBODY TEST | Immco Diagnostics, Inc. | 1999-10-15 | 50 | 0 |
| K982898 | IMMUGLO ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY (ANCA) TEST SYT | Immco Diagnostics, Inc. | 1998-11-30 | 105 | 0 |
| K970177 | ANTI-CARDIOLIPIN ANTIBODY (ACA) SCREEN ELISA | Immco Diagnostics, Inc. | 1997-06-11 | 145 | 0 |
| K964341 | IGA ANTI-GLIADIN (IGA-AGA) ANTIBODY TEST KIT | Immco Diagnostics, Inc. | 1997-05-30 | 211 | 0 |
| K964344 | IGG ANTI-GLIADIN (IGG-AGA) ANTIBODY TEST KIT | Immco Diagnostics, Inc. | 1997-05-30 | 211 | 0 |
| K960370 | THYROGLOBULIN ANTIBODY ELISA | Immco Diagnostics, Inc. | 1996-06-20 | 147 | 0 |
| K960369 | THYROID PEROXIDASE ANTIBODY ELISA | Immco Diagnostics, Inc. | 1996-06-20 | 147 | 0 |
| K933786 | ANTI-CARDIOLIPIN ANTIBODY (IGG-ACA) TEST | Immco Diagnostics, Inc. | 1995-03-07 | 580 | 0 |
| K933788 | ANTI-CARDIOLIPIN ANTIBODY (IGM-ACA) TEST | Immco Diagnostics, Inc. | 1995-03-07 | 580 | 0 |
| K933784 | ANTI-CARDIOLIPIN ANTIBODY (IGA-ACA)TEST) | Immco Diagnostics, Inc. | 1995-03-07 | 580 | 0 |
| K943585 | ANTI-HISTONE ANIBODY TEST | Immco Diagnostics, Inc. | 1995-01-20 | 182 | 0 |
| K942272 | IGM RHEUMATOID FACTOR | Immco Diagnostics, Inc. | 1994-09-26 | 139 | 0 |
| K913360 | ANTI-RETICULIN ANTIBODY (ARA) TEST | Immco Diagnostics, Inc. | 1994-09-26 | 1155 | 0 |
| K912551 | ANTI-ENDOMYSIAL ANTIBODY TEST | Immco Diagnostics, Inc. | 1993-06-09 | 729 | 0 |
| K921658 | ANTI-DSDNA ANTIBODY TEST | Immco Diagnostics, Inc. | 1993-03-22 | 349 | 0 |
| K920385 | ANTI-ENA ANTIBODY TEST (SM) | Immco Diagnostics, Inc. | 1992-03-30 | 60 | 0 |
| K920383 | ANTI-ENA ANTIBODY TEST [SS-A (RO)] | Immco Diagnostics, Inc. | 1992-03-30 | 60 | 0 |
| K920384 | ANIT-ENA ANTIBODY TEST [SS-B (LA)] | Immco Diagnostics, Inc. | 1992-03-30 | 60 | 0 |
| K920386 | ANTI-ENA ANTIBODY TEST KIT | Immco Diagnostics, Inc. | 1992-03-30 | 60 | 0 |
| K905531 | LUPUS(LE)-LATEX TEST | Immco Diagnostics, Inc. | 1991-01-25 | 46 | 0 |
| K903314 | ANTI-SCI-70 ANTIBODY TEST | Immco Diagnostics, Inc. | 1990-08-14 | 21 | 0 |
| K895338 | ANTI-RNP AND ANTI-SM ANTIBODY TEST | Immco Diagnostics, Inc. | 1989-10-17 | 47 | 0 |
| K895339 | ANTI-SS-A (RO) AND ANTI-SS-B (LA) ANTIBODY TEST | Immco Diagnostics, Inc. | 1989-10-04 | 34 | 0 |
| K891098 | ANTI-SKIN ANTIBODY TEST(MONKEY ESOPHAGUS SECTIONS) | Immco Diagnostics, Inc. | 1989-03-22 | 20 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda