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 |