INFLAMMA DRY
FDA 510(k) clearance K132066 · decided 2013-11-21
Clearance details
- K-number
- K132066
- Device name
- INFLAMMA DRY
- Applicant
- Rapid Pathogen Screening, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-07-03
- Decision date
- 2013-11-21
- Days to decision
- 141 days
- Clearance type
- Traditional
- Product code
- PFQ
- Device class
- 1
- Regulation number
- 862.1540
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Sarasota, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests recall (Z-1636-2024) | Quidel Corporation | 2024-04-24 |
| QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests recall (Z-1637-2024) | Quidel Corporation | 2024-04-24 |