CKB · Acid Phosphatase, Naphthyl Phosphate
Clinical Chemistry · 21 CFR 862.1020 · Class 2
Overview
| Product Code | CKB |
|---|---|
| Device Name | Acid Phosphatase, Naphthyl Phosphate |
| 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 (20 of 24)
Showing 20 most recent of 24 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K053612 | DRI-STAT ACID PHOSPHATASE REAGENT | Beckman Coulter, Inc. | Apr 26, 2006 | SESE |
| K023840 | ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650 | Bayer Diagnostics Corp. | Jan 7, 2003 | SESE |
| K991010 | ACP | Abbott Diagnostics Mfg., Inc. | May 19, 1999 | SESE |
| K981743 | OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER | Olympus America, Inc. | Jun 9, 1998 | SESE |
| K974695 | COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES WITH B-GLUCURONIDASE (BNZGL) | Roche Diagnostic Systems, Inc. | May 21, 1998 | SESE |
| K963640 | OLYMPUS ACID PHOSPHATASE REAGENT | Olympus America, Inc. | Feb 18, 1997 | SESE |
| K943366 | IL TEST ACID PHOSPHATASE | Instrumentation Laboratory CO | Jan 29, 1996 | SESE |
| K902543 | ACID PHOSPHOTASE REAGENT TEST AND KIT | Crestat Diagnostics, Inc. | Sep 7, 1990 | SESE |
| K902495 | ACID PHOSPHATASE REAGENT SET | Tech Intl. Co. | Jul 16, 1990 | SESE |
| K892393 | ACID PHOSPHATASE REAGENT | Medical Analysis Systems, Inc. | Jul 20, 1989 | SESE |
| K884747 | TECHNICON CHEM 1 SYSTEM ACID PHOSPHATASE (TOTAL) | Technicon Instruments Corp. | Jan 30, 1989 | SESE |
| K881204 | ACP KINETIC TEST (ACID PHOSPHATASE TEST) | Sclavo, Inc. | Apr 28, 1988 | SESE |
| K880798 | ACID PHOSPHATASE REAGENT | Trace America, Inc. | Apr 18, 1988 | SESE |
| K875209 | ACID PHOSPHATASE (KINETIC) CAT. # 320-06 | Diagnostic Chemicals, Ltd. (Usa) | Feb 1, 1988 | SESE |
| K863851 | ACID PHOSPHATASE (ACP) REAGENT | Sigma Diagnostics, Inc. | Oct 16, 1986 | SESE |
| K861675 | ACID PHOSPHATASE PROCEDURE | Data Medical Associates, Inc. | May 29, 1986 | SESE |
| K854223 | VES-TEC/VES-MATIC | Marvic Interpharma, Inc. | Apr 4, 1986 | SESE |
| K853949 | DEMAND ACID PHOSPHATASE REAGENT | Cooper Biomedical, Inc. | Oct 16, 1985 | SESE |
| K850902 | DATA ZYME ACID PHOSPHATASE PROCEDURE | Data Medical Associates, Inc. | Mar 20, 1985 | SESE |
| K840661 | PARAMAX ACID PHOSPHATASE REAGENT | American Dade | Apr 4, 1984 | SESE |
Top Applicants
- Data Medical Associates, Inc. — 2 clearances
- Olympus America, Inc. — 2 clearances
- Abbott Diagnostics Mfg., Inc. — 1 clearance
- American Dade — 1 clearance
- Bayer Diagnostics Corp. — 1 clearance
