The following data is part of a premarket notification filed by Medivators Inc. with the FDA for Rapicide Pa High-level Disinfectant Test Strips.
| Device ID | K152394 |
| 510k Number | K152394 |
| Device Name: | Rapicide PA High-Level Disinfectant Test Strips |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | MEDIVATORS INC. 14605 28TH AVE NORTH Minneapolis, MN 55447 |
| Contact | Megan Dickey |
| Correspondent | Brent Geiger MEDIVATORS INC. 14605 28TH AVE NORTH Minneapolis, MN 55447 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-24 |
| Decision Date | 2016-03-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30677964064075 | K152394 | 000 |