FLUOROGEN PAP FIA
Device Facts
| Record ID | K820724 |
|---|---|
| Device Name | FLUOROGEN PAP FIA |
| Applicant | Biogenex Laboratories |
| Product Code | JFH · Clinical Chemistry |
| Decision Date | Apr 14, 1982 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1020 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An acid phosphatase (total or prostatic) test system is a device intended to measure the activity of the acid phosphatase enzyme in plasma and serum.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
