The following data is part of a premarket notification filed by Pharmacia & Upjohn Co. with the FDA for Unicap Gliadin Iga Assay.
| Device ID | K982533 |
| 510k Number | K982533 |
| Device Name: | UNICAP GLIADIN IGA ASSAY |
| Classification | Antibodies, Gliadin |
| Applicant | PHARMACIA & UPJOHN CO. 7000 PORTAGE RD. Kalamazoo, MI 49001 |
| Contact | Karen E Matis |
| Correspondent | Karen E Matis PHARMACIA & UPJOHN CO. 7000 PORTAGE RD. Kalamazoo, MI 49001 |
| Product Code | MST |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-20 |
| Decision Date | 1998-10-22 |
| Summary: | summary |