The following data is part of a premarket notification filed by Di-chem, Inc. with the FDA for Formasure Test Reagent.
| Device ID | K905217 |
| 510k Number | K905217 |
| Device Name: | FORMASURE TEST REAGENT |
| Classification | Dialyzer Reprocessing System |
| Applicant | DI-CHEM, INC. 10550 COUNTY RD. 81 Maple Grove, MN 55369 |
| Contact | Dwayne K Buchholz |
| Correspondent | Dwayne K Buchholz DI-CHEM, INC. 10550 COUNTY RD. 81 Maple Grove, MN 55369 |
| Product Code | LIF |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-20 |
| Decision Date | 1991-04-09 |