Data / Medical devices / United States / Immco Diagnostics, Inc.
Immco Diagnostics, Inc.: FDA-registered device maker in Williamsville, NY, United States, 19 510(k) clearances
Immco Diagnostics, Inc. is registered with the FDA (registration 3015376545) in Williamsville, NY, United States. It lists 19 device types. The FDA files 19 510(k) clearances under its listings, the newest dated June 5, 2018. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3015376545
- Address
- 10 Earhart Drive --, Williamsville, NY, United States, 14221
- Owner or operator
- IMMCO DIAGNOSTICS, INC. (1315336)
- Roles
- Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
- First device listed
- July 8, 1992
- Registered through
- 2026
- Brand names listed
- Anti-Endomysial Antibody (EMA) Test, Anti-Endomysial Antibody Test, Anti-Native DNA Antibody Test, Anti-Neutrophil Cytoplasmic ANCA Ab, Anti-Reticulin Antibody Test, Anti-Skin Ab (Monkey Esophaugus), Antinuclear Ab (Mouse Liver), Antinuclear Ab Test (HEP-2 Cells) and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 5, 2018 | K172745 | ImmuGlo HEp-2 Elite IFA | DHN | Substantially Equivalent | Immco Diagnostics, Inc. | accessdata.fda.gov |
| October 23, 2017 | K172254 | Lyme B. burgdorferi (IgM) MarStripe Test | LSR | Substantially Equivalent | Trinity Biotech | accessdata.fda.gov |
| February 1, 2017 | K163095 | Lyme B. burgdorferi (IgG) MarStripe Test | LSR | Substantially Equivalent | Trinity Biotech | accessdata.fda.gov |
| September 23, 2015 | K143736 | ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA | DHR | Substantially Equivalent | Immco Diagnostics, Inc. | accessdata.fda.gov |
| March 31, 2015 | K142781 | ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enhanced Sm Antibody ELISA, ImmuLisa Enhanced RNP Antibody ELISA | LLL | Substantially Equivalent | Immco Diagnostics, Inc. | accessdata.fda.gov |
| December 9, 2010 | K101319 | IMMULISA DSDNA ANTIBODY ELISA | LRM | Substantially Equivalent | Immco Diagnostics, Inc. | accessdata.fda.gov |
| October 7, 2010 | K092600 | IMMULISA PR3 ANTIBODY ELISA | MOB | Substantially Equivalent | Immco Diagnostics, Inc. | accessdata.fda.gov |
| October 7, 2010 | K092599 | IMMULISA MPO ANTIBODY ELISA | MOB | Substantially Equivalent | Immco Diagnostics, Inc. | accessdata.fda.gov |
| March 10, 2010 | K091520 | IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA | MVM | Substantially Equivalent | Immco Diagnostics, Inc. | accessdata.fda.gov |
| May 25, 2006 | K060157 | IMMUGLO ANTI-ENDOMYSIAL ANTIBODY IFA | MVM | Substantially Equivalent | Immco Diagnostics, Inc. | accessdata.fda.gov |
| November 30, 1998 | K982898 | IMMUGLO ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY (ANCA) TEST SYTEM | MOB | Substantially Equivalent | Immco Diagnostics, Inc. | accessdata.fda.gov |
| September 26, 1994 | K913360 | ANTI-RETICULIN ANTIBODY (ARA) TEST | DBL | Substantially Equivalent | Immco Diagnostics, Inc. | accessdata.fda.gov |
| June 9, 1993 | K912551 | ANTI-ENDOMYSIAL ANTIBODY TEST | DBL | Substantially Equivalent | Immco Diagnostics, Inc. | accessdata.fda.gov |
| March 22, 1989 | K891099 | ANTI-SKIN ANTIBODY TEST(MONKEY/GUIN PIG ESOPH SEC) | DBL | Substantially Equivalent | Immco Diagnostics, Inc. | accessdata.fda.gov |
| March 22, 1989 | K891098 | ANTI-SKIN ANTIBODY TEST(MONKEY ESOPHAGUS SECTIONS) | DBL | Substantially Equivalent | Immco Diagnostics, Inc. | accessdata.fda.gov |
| November 4, 1988 | K884400 | ANTI-NATIVE DNA ANTIBODY TEST (CRITHIDIA LUCILIAE) | DHN | Substantially Equivalent | Immco Diagnostics, Inc. | accessdata.fda.gov |
| October 27, 1988 | K883949 | ANTINUCLEAR ANTIBODY (ANA) TEST (MOUSE LIVER SECT) | LKJ | Substantially Equivalent | Immco Diagnostics, Inc. | accessdata.fda.gov |
| October 27, 1988 | K883883 | ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 CELLS) | LKJ | Substantially Equivalent | Immco Diagnostics, Inc. | accessdata.fda.gov |
| October 19, 1988 | K883915 | AUTOANTIBODY TEST SYSTEM (MOUSE KIDNEY/STOMACH) | DBL | Substantially Equivalent | Immco Diagnostics, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
- All makers of Culture Media, Non-Propagating Transport
- All makers of Antinuclear Antibody, Antigen, Control
- All makers of Autoantibodies, Endomysial(Tissue Transglutaminase)
- All makers of System, Test, Rheumatoid Factor
- All makers of Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Updated June 5, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.