510(k) K132066 ยท PFQ Mmp-9 Test System
INFLAMMA DRY
| Applicant | Rapid Pathogen Screening, Inc., Sarasota FL, US |
| Decision | Substantially Equivalent, Nov 21, 2013 |
| Received | Jul 3, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132066
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 24, 2024 | Quidel Corporation QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests Open, Classified |
PFQ | None listed |
| Apr 24, 2024 | Quidel Corporation QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests Open, Classified |
PFQ | None listed |
| Jun 22, 2017 | Quidel Corporation InflammaDry(R) AN RPS DIAGNOSTIC SOLUTION, Sample Collectors
InflammaDry(R) is a rapid, immunoassay test for the visual, qualitative, in vitro detection of elevated levels of the MMP-9 protein in hum Terminated |
PFQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.