The following data is part of a premarket notification filed by Serim Research Corp. with the FDA for Serim Leukocyte Esterase Test Strips.
| Device ID | K000578 |
| 510k Number | K000578 |
| Device Name: | SERIM LEUKOCYTE ESTERASE TEST STRIPS |
| Classification | Test, Urine Leukocyte |
| 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 | LJX |
| CFR Regulation Number | 864.7675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-22 |
| Decision Date | 2000-05-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M17451221 | K000578 | 000 |