# Immco Diagnostics, Inc.

- Location (FDA's records): Buffalo, NY
- FDA decisions: 55 (1988–2018): 55 510(k) clearances
- Product codes: LLL (8), MVM (6), MID (5), DBL (5), MOB (4), MST (4), MSV (3), LJM (3), DHN (2), NBT (2), JZO (2), LKJ (2)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 4 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Techlab, Inc.: 2 (https://510kreport.com/company/techlab)
- Mbl International Corporation: 2 (https://510kreport.com/company/mbl-international)

## Its most-cited devices
- K032860: Immulisa Anti-Saccharomyces Cerevisiae Antibody (Asca) (Iga) (2004), cited by 1
- K891098: Anti-Skin Antibody Test (Monkey Esophagus Sections) (1989), cited by 1
- K032850: Immulisa Anti-Saccharomyces Cerevisiae Antibody (Asca) (Igg) (2004), cited by 1
- K891099: Anti-Skin Antibody Test (Monkey/Guin Pig Esoph Sec) (1989), cited by 1

## Recent decisions
- K172745: ImmuGlo HEp-2 Elite IFA (Jun 5, 2018)
- K172078: ImmuLisa Enhanced RNA POL III Antibody ELISA (Mar 30, 2018)
- K163133: ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA (Aug 8, 2017)
- K163177: ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA (Jul 28, 2017)
- K162788: ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISA (Jun 19, 2017)
- K151559: ImmuLisa Enhanced Centromere Antibody ELISA (Mar 11, 2016)
- 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 (Sep 23, 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 (Mar 31, 2015)

Source page: https://510kreport.com/company/immco-diagnostics