The following data is part of a premarket notification filed by Utah Bioresearch, Inc. with the FDA for Minifuge, Model 70.
| Device ID | K882149 |
| 510k Number | K882149 |
| Device Name: | MINIFUGE, MODEL 70 |
| Classification | Antigen, Latex Agglutination, Trichinella Spiralis |
| Applicant | UTAH BIORESEARCH, INC. SUITE 222 410 CHIPETA WAY Salt Lake City, UT 84108 |
| Contact | William S Partridge |
| Correspondent | William S Partridge UTAH BIORESEARCH, INC. SUITE 222 410 CHIPETA WAY Salt Lake City, UT 84108 |
| Product Code | GPG |
| CFR Regulation Number | 866.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-23 |
| Decision Date | 1988-07-01 |