Product code JFH
- Device name
- Acid Phosphatase (Prostatic), Tartrate Inhibited
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1020
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K000257 | IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6 | Diagnostic Products Corp. | 2000-02-23 |
| K981573 | UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE | United Biotech, Inc. | 1998-09-15 |
| K964756 | PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT | Wano-Tech Corp. | 1997-04-23 |
| K931701 | IMMULITE PAP | Diagnostic Products Corp. | 1994-01-27 |
| K925377 | IMX PAP | Abbott Laboratories | 1993-01-13 |
| K921745 | HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO | Hybritech, Inc. | 1992-07-30 |
| K902937 | MILENIA PAP IRMA CATALOG #: MKPA1, X | Diagnostic Products Corp. | 1990-09-21 |
| K901933 | COAT-A-COUNT PAP IRMA, CATLOG# 1KPA1, 1KPA2 | Diagnostic Products Corp. | 1990-06-28 |
| K895723 | IRMA-COUNT(TM) PAP, (RKPA1, RKPA2) | Diagnostic Products Corp. | 1989-10-31 |
| K893508 | PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI | Baxter Healthcare Corp | 1989-08-04 |
| K884748 | TECHNICON CHEM 1 SYSTEM ACID PHOS (PROSTATIC) | Technicon Instruments Corp. | 1989-01-30 |
| K873903 | ABBOTT PAP-EIA | Abbott Laboratories | 1987-12-01 |
| K864945 | TANDEM(R) M-PAK(TM) PAP IMMUNOENZYMETRIC ASSAY | Hybritech, Inc. | 1987-01-05 |
| K863832 | NAPHTHYL PHOSPHATE, ACID PHOSPHATASE | Pointe Scientific, Inc., | 1986-12-16 |
| K852845 | PROSTATIC ACID PHOSPHATASE RADIOIMMUNOASSAY | Diagnostic Products Corp. | 1985-09-04 |
| K851950 | TANDEM E PAP | Hybritech, Inc. | 1985-06-25 |
| K844679 | DSL PAP RIA -DSL#3100 | Diagnostic Systems Laboratories, Inc. | 1985-04-29 |
| K844968 | EPICHROME PAP | Cetus Corp. | 1985-02-07 |
| K843230 | VENTREZYME PAP KIT IMMUNOASSAY PROSTATIC | Ventrex Laboratories, Inc. | 1984-09-04 |
| K831670 | ORTHO*PAP-IA ENDOGENOUS ENZYME IMMUNO | Ortho Diagnostic Systems, Inc. | 1983-08-24 |
| K831105 | CORDIA PAP | Cordis Corp. | 1983-05-16 |
| K822298 | DIAGNOSTIC RADIOIMMUNOASSAY FOR QUANTI | Nuclear Medical Laboratories, Inc. | 1982-09-02 |
| K820724 | FLUOROGEN PAP FIA | Biogenex Laboratories | 1982-04-14 |
| K812925 | ABBOTT PAP-EIA | Abbott Laboratories | 1982-01-19 |
| K813261 | RIAGEN PAP RIA | Biogenex Laboratories | 1981-12-17 |
| K811959 | TANDEM PAP KIT - (PARTS I & II) | Hybritech, Inc. | 1981-09-01 |
| K811757 | NEIA PAP ENZYMEIMMUNOASSAY | New England Immunology Assoc. | 1981-08-13 |
| K811274 | PROSTATIC ACID PHOSPHATASE RADIOIMM. KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-05-27 |
| K811169 | PROSTATIC ACID PHOSPHATASE (PAP) RDA KIT | Amersham Corp. | 1981-05-15 |
| K803234 | ESKACHEM PAP REAGENT | Smithkline Diagnostics, Inc. | 1981-02-26 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 14560189210612 | ST AIA-PACK PAP | TOSOH CORPORATION | 2016-09-24 |
| 04560189211575 | AIA-PACK PAP SAMPLE DILUTING SOLUTION | TOSOH CORPORATION | 2016-09-24 |
| 04560189211582 | AIA-PACK PAP CALIBRATOR SET | TOSOH CORPORATION | 2016-09-24 |
| 00630414961804 | IMMULITE® 2000 Systems PAP | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2016-09-24 |
| 00630414964355 | IMMULITE®/IMMULITE® 1000 Systems PAP | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2016-09-24 |
| 00630414996639 | IMMULITE® Systems PAP CONTROL PAP | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2016-09-24 |
| 00811727010001 | Pointe Scientific, Inc. | HORIBA INSTRUMENTS INCORPORATED | 2016-08-31 |
| 00811727012210 | Pointe Scientific, Inc. | HORIBA INSTRUMENTS INCORPORATED | 2016-08-31 |