The following data is part of a premarket notification filed by Serim Research Corp. with the FDA for Cidex Opa Solution Test Strip.
| Device ID | K992341 |
| 510k Number | K992341 |
| Device Name: | CIDEX OPA SOLUTION TEST STRIP |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | SERIM RESEARCH CORP. 23565 REEDY DR. Elkhart, IN 46514 |
| Contact | James E Christner |
| Correspondent | James E Christner SERIM RESEARCH CORP. 23565 REEDY DR. 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 | 1999-07-13 |
| Decision Date | 1999-11-23 |
| Summary: | summary |