The following data is part of a premarket notification filed by Serim Research Corp. with the FDA for Serim Hisense Test Kit.
Device ID | K952215 |
510k Number | K952215 |
Device Name: | SERIM HISENSE TEST KIT |
Classification | Subsystem, Water Purification |
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 | FIP |
CFR Regulation Number | 876.5665 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-05-11 |
Decision Date | 1995-08-09 |