The following data is part of a premarket notification filed by Immco Diagnostics, Inc. with the FDA for Immulisa Celiac G+ (gliadin) Iga And Igg Antibody Elisa.
| Device ID | K091522 |
| 510k Number | K091522 |
| Device Name: | IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA |
| Classification | Antibodies, Gliadin |
| Applicant | IMMCO DIAGNOSTICS, INC. 60 PINEVIEW DR. Buffalo, NY 14228 -2120 |
| Contact | Kevin Lawson |
| Correspondent | Kevin Lawson IMMCO DIAGNOSTICS, INC. 60 PINEVIEW DR. Buffalo, NY 14228 -2120 |
| Product Code | MST |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-22 |
| Decision Date | 2010-02-04 |