The following data is part of a premarket notification filed by Serim Research Corp. with the FDA for Serim(tm) Bicarb Ph Reagent Strips.
| Device ID | K945491 |
| 510k Number | K945491 |
| Device Name: | SERIM(TM) BICARB PH REAGENT STRIPS |
| Classification | Strip, Dialysate Ph Indicator |
| Applicant | SERIM RESEARCH CORP. P.O. BOX 4002 Elkhart, IN 46514 -0002 |
| Contact | Robert C Boguslaski |
| Correspondent | Robert C Boguslaski SERIM RESEARCH CORP. P.O. BOX 4002 Elkhart, IN 46514 -0002 |
| Product Code | MNV |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-08 |
| Decision Date | 1995-02-01 |