The following data is part of a premarket notification filed by Serim Research Corp. with the FDA for Rapicide Opa-28 Test Strip.
| Device ID | K120652 |
| 510k Number | K120652 |
| Device Name: | RAPICIDE OPA-28 TEST STRIP |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | SERIM RESEARCH CORP. 3506 Reedy Dr Elkhart, IN 46514 |
| Contact | Patricia Rupchock |
| Correspondent | Patricia Rupchock SERIM RESEARCH CORP. 3506 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 | 2012-03-02 |
| Decision Date | 2012-10-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30677964100957 | K120652 | 000 |
| 20304040005198 | K120652 | 000 |
| 00732224000541 | K120652 | 000 |