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 |