CKE · Acid Phosphatase, Thymolphthale Inmonophosphate
Clinical Chemistry · 21 CFR 862.1020 · Class 2
Overview
| Product Code | CKE |
|---|---|
| Device Name | Acid Phosphatase, Thymolphthale Inmonophosphate |
| 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.
Recent Cleared Devices (9 of 9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K914167 | CLINICAL CHEM.ANAL.ACID,PROSTATIC ACID PHOSPHATASE | Eastman Kodak Company | Mar 17, 1992 | SESE |
| K915705 | ACID PHOSPHATASE REAGENT SET | Tech Intl. Co. | Feb 27, 1992 | SESE |
| K873726 | ACID PHOSPHATASE TEST | King Diagnostics, Inc. | Jan 27, 1988 | SESE |
| K864230 | DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM | E.I. Dupont DE Nemours & Co., Inc. | Nov 28, 1986 | SESE |
| K860476 | ACID PHOSPHATASE REAGENT SET | Sterling Diagnostics, Inc. | Mar 5, 1986 | SESE |
| K843380 | ACID PHOSPHATASE ASSAY KIT | Diagnostic Chemicals, Ltd. (Usa) | Sep 20, 1984 | SESE |
| K821526 | ACID PHOSPHATASE REAGENT SET | Anco Medical Reagents & Assoc. | Jun 10, 1982 | SESE |
| K800693 | STANBIO PROSTATIC ACID PHOSPHATASE TEST | Stanbio Laboratory | Apr 16, 1980 | SESE |
| K790524 | DATA-ZYME ACIA PHOSPHATASE PROCEDURE | Data Medical Associates, Inc. | May 23, 1979 | SESE |
Top Applicants
- Anco Medical Reagents & Assoc. — 1 clearance
- Data Medical Associates, Inc. — 1 clearance
- Diagnostic Chemicals, Ltd. (Usa) — 1 clearance
- E.I. Dupont DE Nemours & Co., Inc. — 1 clearance
- Eastman Kodak Company — 1 clearance
