FDA Product Code
FDA Product Code JFH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1020
510(k) Clearances — 45 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K000257 | IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6 | Diagnostic Products Corp. | 2000-02-23 | Traditional | PDF ↗ |
| K981573 | UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE | United Biotech, Inc. | 1998-09-15 | Traditional | PDF ↗ |
| K964756 | PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT | Wano-Tech Corp. | 1997-04-23 | Traditional | PDF ↗ |
| K931701 | IMMULITE PAP | Diagnostic Products Corp. | 1994-01-27 | Traditional | PDF ↗ |
| K925377 | IMX PAP | Abbott Laboratories | 1993-01-13 | Traditional | PDF ↗ |
| K921745 | HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO | Hybritech, Inc. | 1992-07-30 | Traditional | PDF ↗ |
| K902937 | MILENIA PAP IRMA CATALOG #: MKPA1, X | Diagnostic Products Corp. | 1990-09-21 | Traditional | PDF ↗ |
| K901933 | COAT-A-COUNT PAP IRMA, CATLOG# 1KPA1, 1KPA2 | Diagnostic Products Corp. | 1990-06-28 | Traditional | PDF ↗ |
| K895723 | IRMA-COUNT(TM) PAP, (RKPA1, RKPA2) | Diagnostic Products Corp. | 1989-10-31 | Traditional | PDF ↗ |
| K893508 | PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI | Baxter Healthcare Corp | 1989-08-04 | Traditional | PDF ↗ |
| K884748 | TECHNICON CHEM 1 SYSTEM ACID PHOS (PROSTATIC) | Technicon Instruments Corp. | 1989-01-30 | Traditional | PDF ↗ |
| K873903 | ABBOTT PAP-EIA | Abbott Laboratories | 1987-12-01 | Traditional | PDF ↗ |
| K864945 | TANDEM(R) M-PAK(TM) PAP IMMUNOENZYMETRIC ASSAY | Hybritech, Inc. | 1987-01-05 | Traditional | PDF ↗ |
| K863832 | NAPHTHYL PHOSPHATE, ACID PHOSPHATASE | Pointe Scientific, Inc., | 1986-12-16 | Traditional | PDF ↗ |
| K852845 | PROSTATIC ACID PHOSPHATASE RADIOIMMUNOASSAY | Diagnostic Products Corp. | 1985-09-04 | Traditional | PDF ↗ |
| K851950 | TANDEM E PAP | Hybritech, Inc. | 1985-06-25 | Traditional | PDF ↗ |
| K844679 | DSL PAP RIA -DSL#3100 | Diagnostic Systems Laboratories, Inc. | 1985-04-29 | Traditional | PDF ↗ |
| K844968 | EPICHROME PAP | Cetus Corp. | 1985-02-07 | Traditional | PDF ↗ |
| K843230 | VENTREZYME PAP KIT IMMUNOASSAY PROSTATIC | Ventrex Laboratories, Inc. | 1984-09-04 | Traditional | PDF ↗ |
| K831670 | ORTHO*PAP-IA ENDOGENOUS ENZYME IMMUNO | Ortho Diagnostic Systems, Inc. | 1983-08-24 | Traditional | PDF ↗ |
| K831105 | CORDIA PAP | Cordis Corp. | 1983-05-16 | Traditional | PDF ↗ |
| K822298 | DIAGNOSTIC RADIOIMMUNOASSAY FOR QUANTI | Nuclear Medical Laboratories, Inc. | 1982-09-02 | Traditional | PDF ↗ |
| K820724 | FLUOROGEN PAP FIA | Biogenex Laboratories | 1982-04-14 | Traditional | PDF ↗ |
| K812925 | ABBOTT PAP-EIA | Abbott Laboratories | 1982-01-19 | Traditional | PDF ↗ |
| K813261 | RIAGEN PAP RIA | Biogenex Laboratories | 1981-12-17 | Traditional | PDF ↗ |
| K811959 | TANDEM PAP KIT - (PARTS I & II) | Hybritech, Inc. | 1981-09-01 | Traditional | PDF ↗ |
| K811757 | NEIA PAP ENZYMEIMMUNOASSAY | New England Immunology Assoc. | 1981-08-13 | Traditional | PDF ↗ |
| K811274 | PROSTATIC ACID PHOSPHATASE RADIOIMM. KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-05-27 | Traditional | PDF ↗ |
| K811169 | PROSTATIC ACID PHOSPHATASE (PAP) RDA KIT | Amersham Corp. | 1981-05-15 | Traditional | PDF ↗ |
| K803234 | ESKACHEM PAP REAGENT | Smithkline Diagnostics, Inc. | 1981-02-26 | Traditional | PDF ↗ |
| K810232 | LEECO P.A.P. - QUANT DIAGNOSTIC KIT | Leeco Diagnostics, Inc. | 1981-02-10 | Traditional | PDF ↗ |
| K802886 | NUCLI-PAP TM-(I125)-PAP RADIOIMMUNOAS- | Nuclear Diagnostics, Inc. | 1981-01-28 | Traditional | PDF ↗ |
| K803043 | RIAPHASE (125I) PROST. ACID PHOSPH. KIT | Beckman Instruments, Inc. | 1981-01-02 | Traditional | PDF ↗ |
| K802153 | CBC PAP TEST KIT | Calbiochem-Behring Corp. | 1980-11-12 | Traditional | PDF ↗ |
| K801988 | NORDICLAB PROSTATIC ACID PHOSPHATASE RIA | Nordiclab Intl. | 1980-09-26 | Traditional | PDF ↗ |
| K792652 | LEECO P.A.P. QUANT. DIAGNOSTIC KIT | Leeco Diagnostics, Inc. | 1980-01-16 | Traditional | PDF ↗ |
| K792059 | S.F.-P.A.P. TEST COUNTER IMMUNOELECTRO | S.F. Biologicals, Inc. | 1979-12-13 | Traditional | PDF ↗ |
| K792405 | ELVI ACID & PROSTATIC PHOSPHATASE | Volu Sol Medical Industries | 1979-12-07 | Traditional | PDF ↗ |
| K791497 | PROSTATIC ACID RADIOIMMUNOASSAY TEST | Clinical Assays, Inc. | 1979-12-04 | Traditional | PDF ↗ |
| K791735 | PAP RIA KIT | Nuclear Medical Systems, Inc. | 1979-11-15 | Traditional | PDF ↗ |
| K792043 | PAP-CHECK RIA KIT | Serono Laboratories, Inc. | 1979-10-30 | Traditional | PDF ↗ |
| K790580 | RIA KIT, PROSTATIC ACID | Monitor Science Corp. | 1979-05-25 | Traditional | PDF ↗ |
| K790317 | PAP RIA KIT | Yang Laboratories, Inc. | 1979-05-07 | Traditional | PDF ↗ |
| K790817 | RIA KIT, QUANTITATION OF PROSTATIC ACID | New England Nuclear | 1979-05-07 | Traditional | PDF ↗ |
| K790040 | P.A.P. TEST KIT, RIA-ZYME | Mallinckrodt Critical Care | 1979-04-17 | Traditional | PDF ↗ |
Product code JFH · Class II · Clinical Chemistry. Data: openFDA.