Atlas FDA

JFH

45 FDA 510(k) clearances · Product code

59 daysmedian time to decision
123 days90th percentile
45clearances measured

FDA profile

Official device name
Acid Phosphatase (Prostatic), Tartrate Inhibited
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1020
Medical specialty
Clinical Chemistry
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6 (K000257)Diagnostic Products Corp.2000-02-23
UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE (K981573)United Biotech, Inc.1998-09-15
PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT (K964756)Wano-Tech Corp.1997-04-23
IMMULITE PAP (K931701)Diagnostic Products Corp.1994-01-27
IMX PAP (K925377)Abbott Laboratories1993-01-13
HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO (K921745)Hybritech, Inc.1992-07-30
MILENIA PAP IRMA CATALOG #: MKPA1, X (K902937)Diagnostic Products Corp.1990-09-21
COAT-A-COUNT PAP IRMA, CATLOG# 1KPA1, 1KPA2 (K901933)Diagnostic Products Corp.1990-06-28
IRMA-COUNT(TM) PAP, (RKPA1, RKPA2) (K895723)Diagnostic Products Corp.1989-10-31
PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI (K893508)Baxter Healthcare Corp1989-08-04
TECHNICON CHEM 1 SYSTEM ACID PHOS (PROSTATIC) (K884748)Technicon Instruments Corp.1989-01-30
ABBOTT PAP-EIA (K873903)Abbott Laboratories1987-12-01
TANDEM(R) M-PAK(TM) PAP IMMUNOENZYMETRIC ASSAY (K864945)Hybritech, Inc.1987-01-05
NAPHTHYL PHOSPHATE, ACID PHOSPHATASE (K863832)Pointe Scientific, Inc.,1986-12-16
PROSTATIC ACID PHOSPHATASE RADIOIMMUNOASSAY (K852845)Diagnostic Products Corp.1985-09-04
TANDEM E PAP (K851950)Hybritech, Inc.1985-06-25
DSL PAP RIA -DSL#3100 (K844679)Diagnostic Systems Laboratories, Inc.1985-04-29
EPICHROME PAP (K844968)Cetus Corp.1985-02-07
VENTREZYME PAP KIT IMMUNOASSAY PROSTATIC (K843230)Ventrex Laboratories, Inc.1984-09-04
ORTHO*PAP-IA ENDOGENOUS ENZYME IMMUNO (K831670)Ortho Diagnostic Systems, Inc.1983-08-24
CORDIA PAP (K831105)Cordis Corp.1983-05-16
DIAGNOSTIC RADIOIMMUNOASSAY FOR QUANTI (K822298)Nuclear Medical Laboratories, Inc.1982-09-02
FLUOROGEN PAP FIA (K820724)Biogenex Laboratories1982-04-14
ABBOTT PAP-EIA (K812925)Abbott Laboratories1982-01-19
RIAGEN PAP RIA (K813261)Biogenex Laboratories1981-12-17
TANDEM PAP KIT - (PARTS I & II) (K811959)Hybritech, Inc.1981-09-01
NEIA PAP ENZYMEIMMUNOASSAY (K811757)New England Immunology Assoc.1981-08-13
PROSTATIC ACID PHOSPHATASE RADIOIMM. KIT (K811274)Bd Becton Dickinson Vacutainer Systems Preanalytic1981-05-27
PROSTATIC ACID PHOSPHATASE (PAP) RDA KIT (K811169)Amersham Corp.1981-05-15
ESKACHEM PAP REAGENT (K803234)Smithkline Diagnostics, Inc.1981-02-26
LEECO P.A.P. - QUANT DIAGNOSTIC KIT (K810232)Leeco Diagnostics, Inc.1981-02-10
NUCLI-PAP TM-(I125)-PAP RADIOIMMUNOAS- (K802886)Nuclear Diagnostics, Inc.1981-01-28
RIAPHASE (125I) PROST. ACID PHOSPH. KIT (K803043)Beckman Instruments, Inc.1981-01-02
CBC PAP TEST KIT (K802153)Calbiochem-Behring Corp.1980-11-12
NORDICLAB PROSTATIC ACID PHOSPHATASE RIA (K801988)Nordiclab Intl.1980-09-26
LEECO P.A.P. QUANT. DIAGNOSTIC KIT (K792652)Leeco Diagnostics, Inc.1980-01-16
S.F.-P.A.P. TEST COUNTER IMMUNOELECTRO (K792059)S.F. Biologicals, Inc.1979-12-13
ELVI ACID & PROSTATIC PHOSPHATASE (K792405)Volu Sol Medical Industries1979-12-07
PROSTATIC ACID RADIOIMMUNOASSAY TEST (K791497)Clinical Assays, Inc.1979-12-04
PAP RIA KIT (K791735)Nuclear Medical Systems, Inc.1979-11-15
PAP-CHECK RIA KIT (K792043)Serono Laboratories, Inc.1979-10-30
RIA KIT, PROSTATIC ACID (K790580)Monitor Science Corp.1979-05-25
PAP RIA KIT (K790317)Yang Laboratories, Inc.1979-05-07
RIA KIT, QUANTITATION OF PROSTATIC ACID (K790817)New England Nuclear1979-05-07
P.A.P. TEST KIT, RIA-ZYME (K790040)Mallinckrodt Critical Care1979-04-17

Track JFH automatically

Every clearance here is in the API, with alerts when new ones post.