SANDARE ACID PHOSPHATASE PROCEDURE
Device Facts
| Record ID | K842516 |
|---|---|
| Device Name | SANDARE ACID PHOSPHATASE PROCEDURE |
| Applicant | Sandare Chemical Co., Inc. |
| Product Code | CJR · Clinical Chemistry |
| Decision Date | Aug 17, 1984 |
| 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.
