The following data is part of a premarket notification filed by Rapid Pathogen Screening, Inc. with the FDA for Inflamma Dry.
| Device ID | K132066 |
| 510k Number | K132066 |
| Device Name: | INFLAMMA DRY |
| Classification | Mmp-9 Test System |
| 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 | PFQ |
| CFR Regulation Number | 862.1540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-03 |
| Decision Date | 2013-11-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30014613336747 | K132066 | 000 |