The following data is part of a premarket notification filed by Serim Research Corp. with the FDA for Serim Formaldehyde Reagent Strips (2.5% -4.0%).
| Device ID | K911629 |
| 510k Number | K911629 |
| Device Name: | SERIM FORMALDEHYDE REAGENT STRIPS (2.5% -4.0%) |
| 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 | 1991-04-11 |
| Decision Date | 1991-06-27 |