510(k) K132066
K132066 is an FDA 510(k) premarket notification submitted by Rapid Pathogen Screening, Inc. for the device "INFLAMMA DRY". The FDA issued a decision of Substantially Equivalent on November 21, 2013. The device falls under product code PFQ (Mmp-9 Test System), a Class I device regulated under 21 CFR 862.1540. Rapid Pathogen Screening, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 21, 2013
- Date Received
- July 3, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mmp-9 Test System
- Device Class
- Class I
- Regulation Number
- 862.1540
- Review Panel
- CH
- Submission Type
A visual, qualitative immunoassay for the in vitro detection of elevated levels of the MMP-9 protein in tear fluid from patients suspected of having dry eye.