ACID PHOSPHATASE (KINETIC) CAT. # 320-06
Device Facts
| Record ID | K875209 |
|---|---|
| Device Name | ACID PHOSPHATASE (KINETIC) CAT. # 320-06 |
| Applicant | Diagnostic Chemicals, Ltd. (Usa) |
| Product Code | CKB · Clinical Chemistry |
| Decision Date | Feb 1, 1988 |
| 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.
