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 | K082352 |
| 510k Number | K082352 |
| Device Name: | SERIM DISINTEK OPA TEST STRIP |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | SERIM RESEARCH CORP. 3506 REEDY DRIVE P.O. BOX 4002 Elkhart, IN 46514 |
| Contact | Patricia A Rupchock |
| Correspondent | Patricia A Rupchock SERIM RESEARCH CORP. 3506 REEDY DRIVE P.O. BOX 4002 Elkhart, IN 46514 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-16 |
| Decision Date | 2008-09-25 |
| Summary: | summary |