JFH · Acid Phosphatase (Prostatic), Tartrate Inhibited
Clinical Chemistry · 21 CFR 862.1020 · Class 2
Overview
| Product Code | JFH |
|---|---|
| Device Name | Acid Phosphatase (Prostatic), Tartrate Inhibited |
| 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 45)
Showing 20 most recent of 45 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K000257 | IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6 | Diagnostic Products Corp. | Feb 23, 2000 | SESE |
| K981573 | UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE | United Biotech, Inc. | Sep 15, 1998 | SESE |
| K964756 | PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT | Wano-Tech Corp. | Apr 23, 1997 | SESE |
| K931701 | IMMULITE PAP | Diagnostic Products Corp. | Jan 27, 1994 | SESE |
| K925377 | IMX PAP | Abbott Laboratories | Jan 13, 1993 | SESE |
| K921745 | HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO | Hybritech, Inc. | Jul 30, 1992 | SESE |
| K902937 | MILENIA PAP IRMA CATALOG #: MKPA1, X | Diagnostic Products Corp. | Sep 21, 1990 | SESE |
| K901933 | COAT-A-COUNT PAP IRMA, CATLOG# 1KPA1, 1KPA2 | Diagnostic Products Corp. | Jun 28, 1990 | SESE |
| K895723 | IRMA-COUNT(TM) PAP, (RKPA1, RKPA2) | Diagnostic Products Corp. | Oct 31, 1989 | SESE |
| K893508 | PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI | Baxter Healthcare Corp | Aug 4, 1989 | SESE |
| K884748 | TECHNICON CHEM 1 SYSTEM ACID PHOS (PROSTATIC) | Technicon Instruments Corp. | Jan 30, 1989 | SESE |
| K873903 | ABBOTT PAP-EIA | Abbott Laboratories | Dec 1, 1987 | SESE |
| K864945 | TANDEM(R) M-PAK(TM) PAP IMMUNOENZYMETRIC ASSAY | Hybritech, Inc. | Jan 5, 1987 | SESE |
| K863832 | NAPHTHYL PHOSPHATE, ACID PHOSPHATASE | Pointe Scientific, Inc., | Dec 16, 1986 | SESE |
| K852845 | PROSTATIC ACID PHOSPHATASE RADIOIMMUNOASSAY | Diagnostic Products Corp. | Sep 4, 1985 | SESE |
| K851950 | TANDEM E PAP | Hybritech, Inc. | Jun 25, 1985 | SESE |
| K844679 | DSL PAP RIA -DSL#3100 | Diagnostic Systems Laboratories, Inc. | Apr 29, 1985 | SESE |
| K844968 | EPICHROME PAP | Cetus Corp. | Feb 7, 1985 | SESE |
| K843230 | VENTREZYME PAP KIT IMMUNOASSAY PROSTATIC | Ventrex Laboratories, Inc. | Sep 4, 1984 | SESE |
| K831670 | ORTHO*PAP-IA ENDOGENOUS ENZYME IMMUNO | Ortho Diagnostic Systems, Inc. | Aug 24, 1983 | SESE |
Top Applicants
- Diagnostic Products Corp. — 6 clearances
- Hybritech, Inc. — 4 clearances
- Abbott Laboratories — 3 clearances
- Biogenex Laboratories — 2 clearances
- Leeco Diagnostics, Inc. — 2 clearances
