The following data is part of a premarket notification filed by Rapid Pathogen Screening with the FDA for Rps Adeno Detector.
| Device ID | K052092 |
| 510k Number | K052092 |
| Device Name: | RPS ADENO DETECTOR |
| Classification | Antigens, Cf (including Cf Control), Adenovirus 1-33 |
| Applicant | RAPID PATHOGEN SCREENING 13946 WOOD DUCK CIRCLE Bradenton, FL 34202 |
| Contact | Robert Sambursky |
| Correspondent | Robert Sambursky RAPID PATHOGEN SCREENING 13946 WOOD DUCK CIRCLE Bradenton, FL 34202 |
| Product Code | GOD |
| CFR Regulation Number | 866.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-02 |
| Decision Date | 2005-11-22 |
| Summary: | summary |