The following data is part of a premarket notification filed by Serim Research Corp. with the FDA for Serim Residual Formaldehyde Reagent Strips.
| Device ID | K914123 |
| 510k Number | K914123 |
| Device Name: | SERIM RESIDUAL FORMALDEHYDE REAGENT STRIPS |
| Classification | Dialyzer Reprocessing System |
| Applicant | SERIM RESEARCH CORP. P.O. BOX 4002 Elkhart, IN 46514 -0002 |
| Contact | Michael Mckenna |
| Correspondent | Michael Mckenna SERIM RESEARCH CORP. P.O. BOX 4002 Elkhart, IN 46514 -0002 |
| Product Code | LIF |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-13 |
| Decision Date | 1992-04-09 |