Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

JFH — Predicate Candidate Screening

45 FDA 510(k) clearances under this product code; the 50 most recent screened below.

59 daysmedian FDA review time

123 days90th percentile

45clearances measured

K-number	Device	Applicant	Decided	Review days
K000257	IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6	Diagnostic Products Corp.	2000-02-23	27
K981573	UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE	United Biotech, Inc.	1998-09-15	134
K964756	PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSP	Wano-Tech Corp.	1997-04-23	147
K931701	IMMULITE PAP	Diagnostic Products Corp.	1994-01-27	296
K925377	IMX PAP	Abbott Laboratories	1993-01-13	82
K921745	HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO	Hybritech, Inc.	1992-07-30	108
K902937	MILENIA PAP IRMA CATALOG #: MKPA1, X	Diagnostic Products Corp.	1990-09-21	80
K901933	COAT-A-COUNT PAP IRMA, CATLOG# 1KPA1, 1KPA2	Diagnostic Products Corp.	1990-06-28	59
K895723	IRMA-COUNT(TM) PAP, (RKPA1, RKPA2)	Diagnostic Products Corp.	1989-10-31	36
K893508	PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI	Baxter Healthcare Corp	1989-08-04	91
K884748	TECHNICON CHEM 1 SYSTEM ACID PHOS (PROSTATIC)	Technicon Instruments Corp.	1989-01-30	77
K873903	ABBOTT PAP-EIA	Abbott Laboratories	1987-12-01	68
K864945	TANDEM(R) M-PAK(TM) PAP IMMUNOENZYMETRIC ASSAY	Hybritech, Inc.	1987-01-05	19
K863832	NAPHTHYL PHOSPHATE, ACID PHOSPHATASE	Pointe Scientific, Inc.,	1986-12-16	77
K852845	PROSTATIC ACID PHOSPHATASE RADIOIMMUNOASSAY	Diagnostic Products Corp.	1985-09-04	61
K851950	TANDEM E PAP	Hybritech, Inc.	1985-06-25	53
K844679	DSL PAP RIA -DSL#3100	Diagnostic Systems Laboratories, Inc.	1985-04-29	150
K844968	EPICHROME PAP	Cetus Corp.	1985-02-07	45
K843230	VENTREZYME PAP KIT IMMUNOASSAY PROSTATIC	Ventrex Laboratories, Inc.	1984-09-04	18
K831670	ORTHO*PAP-IA ENDOGENOUS ENZYME IMMUNO	Ortho Diagnostic Systems, Inc.	1983-08-24	93
K831105	CORDIA PAP	Cordis Corp.	1983-05-16	41
K822298	DIAGNOSTIC RADIOIMMUNOASSAY FOR QUANTI	Nuclear Medical Laboratories, Inc.	1982-09-02	30
K820724	FLUOROGEN PAP FIA	Biogenex Laboratories	1982-04-14	28
K812925	ABBOTT PAP-EIA	Abbott Laboratories	1982-01-19	92
K813261	RIAGEN PAP RIA	Biogenex Laboratories	1981-12-17	27
K811959	TANDEM PAP KIT - (PARTS I & II)	Hybritech, Inc.	1981-09-01	54
K811757	NEIA PAP ENZYMEIMMUNOASSAY	New England Immunology Assoc.	1981-08-13	52
K811274	PROSTATIC ACID PHOSPHATASE RADIOIMM. KIT	Bd Becton Dickinson Vacutainer Systems Preanalytic	1981-05-27	20
K811169	PROSTATIC ACID PHOSPHATASE (PAP) RDA KIT	Amersham Corp.	1981-05-15	17
K803234	ESKACHEM PAP REAGENT	Smithkline Diagnostics, Inc.	1981-02-26	66
K810232	LEECO P.A.P. - QUANT DIAGNOSTIC KIT	Leeco Diagnostics, Inc.	1981-02-10	14
K802886	NUCLI-PAP TM-(I125)-PAP RADIOIMMUNOAS-	Nuclear Diagnostics, Inc.	1981-01-28	72
K803043	RIAPHASE (125I) PROST. ACID PHOSPH. KIT	Beckman Instruments, Inc.	1981-01-02	32
K802153	CBC PAP TEST KIT	Calbiochem-Behring Corp.	1980-11-12	65
K801988	NORDICLAB PROSTATIC ACID PHOSPHATASE RIA	Nordiclab Intl.	1980-09-26	38
K792652	LEECO P.A.P. QUANT. DIAGNOSTIC KIT	Leeco Diagnostics, Inc.	1980-01-16	26
K792059	S.F.-P.A.P. TEST COUNTER IMMUNOELECTRO	S.F. Biologicals, Inc.	1979-12-13	59
K792405	ELVI ACID & PROSTATIC PHOSPHATASE	Volu Sol Medical Industries	1979-12-07	11
K791497	PROSTATIC ACID RADIOIMMUNOASSAY TEST	Clinical Assays, Inc.	1979-12-04	123
K791735	PAP RIA KIT	Nuclear Medical Systems, Inc.	1979-11-15	77
K792043	PAP-CHECK RIA KIT	Serono Laboratories, Inc.	1979-10-30	18
K790580	RIA KIT, PROSTATIC ACID	Monitor Science Corp.	1979-05-25	59
K790317	PAP RIA KIT	Yang Laboratories, Inc.	1979-05-07	81
K790817	RIA KIT, QUANTITATION OF PROSTATIC ACID	New England Nuclear	1979-05-07	10
K790040	P.A.P. TEST KIT, RIA-ZYME	Mallinckrodt Critical Care	1979-04-17	99

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda