The following data is part of a premarket notification filed by Serim Research Corp. with the FDA for Serim Residual Chlorine Test Kit.
| Device ID | K901734 |
| 510k Number | K901734 |
| Device Name: | SERIM RESIDUAL CHLORINE TEST KIT |
| Classification | Filter, Blood, Dialysis |
| 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 | FKJ |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-17 |
| Decision Date | 1990-09-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858293006380 | K901734 | 000 |
| 10858293006325 | K901734 | 000 |