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FDA Product Code

FDA Product Code JMF — Clearance Directory

Device Class
Class II
Assigned Panel
Clinical Chemistry
21 CFR Citation
862.1585

510(k) Clearances — 11 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K944933 IMMULITE (HPL) (HUMAN PLACENTAL PLACTOGEN) Diagnostic Products Corp. 1995-03-10 Traditional PDF ↗
K840588 AMERLEX HUMAN PLACENTAL LACTOGEN Amersham Corp. 1984-04-04 Traditional PDF ↗
K823292 IMMOPHASE TM HPL RADIOIMMUNOASSAY Corning Medical & Scientific 1982-12-28 Traditional PDF ↗
K823201 HUMAN PLACENTAL LACTOGEN KIT Diagnostic Products Corp. 1982-11-29 Traditional PDF ↗
K811370 NATAL-TEC HPL Armkel, LLC 1981-05-29 Traditional PDF ↗
K802454 GESTE FOLLOW KIT DETERM. OF HPL Syn-Kit, Inc. 1980-11-12 Traditional PDF ↗
K791854 CENTRIA HPL RIA Union Carbide Corp. 1979-10-01 Traditional PDF ↗
K790919 HPL RIA KIT Technia Diagnostics , Ltd. 1979-06-28 Traditional PDF ↗
K782099 RIA TEST, NORDICALB HPL Nordiclab Intl. 1979-01-10 Traditional PDF ↗
K771656 PROLACTIN RIA DIAG. KIT Abbott Laboratories 1977-09-22 Traditional PDF ↗
K770659 RIALYZE HPL (RIA) Miles Laboratories, Inc. 1977-05-20 Traditional PDF ↗

Product code JMF · Class II · Clinical Chemistry. Data: openFDA.