The following data is part of a premarket notification filed by Serim Research Corp. with the FDA for Serim Blood Leak Test Strip-2.
| Device ID | K012115 |
| 510k Number | K012115 |
| Device Name: | SERIM BLOOD LEAK TEST STRIP-2 |
| Classification | Detector, Leak, Blood |
| Applicant | SERIM RESEARCH CORP. P.O. BOX 4002 Elkhart, IN 46514 -0002 |
| Contact | Patrica Rupchock |
| Correspondent | Patrica Rupchock SERIM RESEARCH CORP. P.O. BOX 4002 Elkhart, IN 46514 -0002 |
| Product Code | FJD |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-06 |
| Decision Date | 2001-11-30 |
| Summary: | summary |