CJN · Acid Phosphatase, Nitrophenylphosphate
Clinical Chemistry · 21 CFR 862.1020 · Class 2
Overview
| Product Code | CJN |
|---|---|
| Device Name | Acid Phosphatase, Nitrophenylphosphate |
| Regulation | 21 CFR 862.1020 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
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.
Classification Rationale
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.
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.
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K781489 | ACID PHOSPHATASE DIAG. KIT | Sclavo, Inc. | Oct 3, 1978 | SESE |
Top Applicants
- Sclavo, Inc. — 1 clearance
