INFLAMMA DRY— 510(k) K132066
Substantially EquivalentRapid Pathogen Screening, Inc.
FDA 510(k) clearance K132066 for INFLAMMA DRY, Substantially Equivalent on 2013-11-21. Applicant: Rapid Pathogen Screening, Inc.. Device class: 1.
Clearance details
- Applicant
- Rapid Pathogen Screening, Inc.
- Product code
- Code PFQ
- Device class
- Class 1
- Regulation
- 21 CFR 862.1540
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sarasota, FL, US
More clearances from Rapid Pathogen Screening, Inc.
view allRecalls naming K132066
K-number listed on FDA's recall record- Z-1636-2024 — QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests
- Z-1637-2024 — QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests
- Z-2803-2017 — 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 human tears, from patients suspected of having dry eye. InflammaDry is to be used to aid in the diagnosis of dry eye, in conjunction with other methods of clinical evaluation. This test is intended for prescription use at point-of-care sites.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K132066.
Data sourced from openFDA. This site is unofficial and independent of the FDA.