PFQ — Mmp-9 Test System Class I
FDA product code PFQ covers "Mmp-9 Test System", a Class I medical device regulated under 21 CFR 862.1540. Submissions are reviewed by the Clinical Chemistry panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- PFQ
- Device Class
- Class I
- Regulation Number
- 862.1540
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Definition
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K132066 | rapid pathogen screening | INFLAMMA DRY | November 21, 2013 |