The following data is part of a premarket notification filed by Serim Research Corp. with the FDA for Serim D-cide Gta 1.5% Test Strip, Model Part Number 5171.
| Device ID | K092346 |
| 510k Number | K092346 |
| Device Name: | SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 5171 |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | SERIM RESEARCH CORP. 3506 REEDY DR. Elkhart, IN 46561 |
| Contact | Patricia Rupchock |
| Correspondent | Patricia Rupchock SERIM RESEARCH CORP. 3506 REEDY DR. Elkhart, IN 46561 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-04 |
| Decision Date | 2010-01-07 |
| Summary: | summary |