The following data is part of a premarket notification filed by Serim Research Corp. with the FDA for Serim Blood Leak Test Strip.
Device ID | K990206 |
510k Number | K990206 |
Device Name: | SERIM BLOOD LEAK TEST STRIP |
Classification | Detector, Leak, Blood |
Applicant | SERIM RESEARCH CORP. 23565 REEDY DR. Elkhart, IN 46514 |
Contact | Robert J Carrico |
Correspondent | Robert J Carrico SERIM RESEARCH CORP. 23565 REEDY DR. Elkhart, IN 46514 |
Product Code | FJD |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-01-21 |
Decision Date | 1999-04-21 |
Summary: | summary |