510(k) K132066
- Device
- INFLAMMA DRY
- Applicant
- RAPID PATHOGEN SCREENING, INC.
- 510(k) number
- K132066
- Product code
- PFQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-11-21
- Date received
- 2013-07-03
- Regulation
- 862.1540
- Classification name
- Mmp-9 Test System
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Douglas Bueschel
- Address
- 7227 Delainey Ct. Sarasota FL US 34240 34240
FDA Registration Numbers#
- 2024674
- 3015392301
- 3026309985
- 3009746061
- 3033751096
- 3021090658
Source Documents#
Legacy Summary#
summary
FDA Review#
Decision Summary