The following data is part of a premarket notification filed by Rapid Pathogen Screening, Inc. with the FDA for Rps Adeno Detector Plus.
| Device ID | K110722 |
| 510k Number | K110722 |
| Device Name: | RPS ADENO DETECTOR PLUS |
| Classification | Antigens, Cf (including Cf Control), Adenovirus 1-33 |
| Applicant | RAPID PATHOGEN SCREENING, INC. 7227 DELAINEY COURT Sarasota, FL 34240 |
| Contact | Douglas Bueschel |
| Correspondent | Douglas Bueschel RAPID PATHOGEN SCREENING, INC. 7227 DELAINEY COURT Sarasota, FL 34240 |
| Product Code | GOD |
| CFR Regulation Number | 866.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-15 |
| Decision Date | 2011-05-17 |
| Summary: | summary |