The following data is part of a premarket notification filed by Serim Research Corp. with the FDA for Serim Disintek Opa Test Strip.
| Device ID | K081370 |
| 510k Number | K081370 |
| Device Name: | SERIM DISINTEK OPA TEST STRIP |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | SERIM RESEARCH CORP. 3506 REEDY ST. Elkhart, IN 46561 |
| Contact | Patricia Rupchock |
| Correspondent | Patricia Rupchock SERIM RESEARCH CORP. 3506 REEDY ST. 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 | 2008-05-15 |
| Decision Date | 2008-07-11 |
| Summary: | summary |