PFQ · Mmp-9 Test System
Clinical Chemistry · 21 CFR 862.1540 · Class 1
Overview
| Product Code | PFQ |
|---|---|
| Device Name | Mmp-9 Test System |
| Regulation | 21 CFR 862.1540 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
An osmolality test system is a device intended to measure ionic and nonionic solute concentration in body fluids, such as serum and urine. Osmolality measurement is used as an adjunct to other tests in the evaluation of a variety of diseases, including kidney diseases (e.g., chronic progressive renal failure), diabetes insipidus, other endocrine and metabolic disorders, and fluid imbalances.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K132066 | INFLAMMA DRY | Rapid Pathogen Screening, Inc. | Nov 21, 2013 | SESE |
Top Applicants
- Rapid Pathogen Screening, Inc. — 1 clearance
