Home / 510(k) Clearances / K132066

510(k) K132066

INFLAMMA DRY by Rapid Pathogen Screening, Inc. — Product Code PFQ

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.

Other clearances by Rapid Pathogen Screening, Inc.

  • K110722 — RPS ADENO DETECTOR PLUS (May 17, 2011)
  • K052092 — RPS ADENO DETECTOR (November 22, 2005)