The following data is part of a premarket notification filed by Serim Research Corp. with the FDA for Serim Residual Peroxide/renalin Test Kit.
Device ID | K900341 |
510k Number | K900341 |
Device Name: | SERIM RESIDUAL PEROXIDE/RENALIN TEST KIT |
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 | 1990-01-22 |
Decision Date | 1990-07-11 |