COAT-A-COUNT PAP IRMA, CATLOG# 1KPA1, 1KPA2
Device Facts
| Record ID | K901933 |
|---|---|
| Device Name | COAT-A-COUNT PAP IRMA, CATLOG# 1KPA1, 1KPA2 |
| Applicant | Diagnostic Products Corp. |
| Product Code | JFH · Clinical Chemistry |
| Decision Date | Jun 28, 1990 |
| 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.
