JMF · Class II · 21 CFR 862.1585

FDA Product Code JMF: Radioimmunoassay, Human Placental Lactogen

Leading manufacturers include Diagnostic Products Corp., Miles Laboratories, Inc. and Abbott Laboratories.

11
Total
11
Cleared
45d
Avg days
1977
Since

FDA 510(k) Cleared Radioimmunoassay, Human Placental Lactogen Devices (Product Code JMF)

11 devices
1–11 of 11
Cleared Mar 10, 1995
IMMULITE (HPL) (HUMAN PLACENTAL PLACTOGEN)
K944933
Diagnostic Products Corp.
Chemistry · 155d
Cleared Apr 04, 1984
AMERLEX HUMAN PLACENTAL LACTOGEN
K840588
Amersham Corp.
Chemistry · 55d
Cleared Dec 28, 1982
IMMOPHASE TM HPL RADIOIMMUNOASSAY
K823292
Corning Medical & Scientific
Chemistry · 53d
Cleared Nov 29, 1982
HUMAN PLACENTAL LACTOGEN KIT
K823201
Diagnostic Products Corp.
Chemistry · 34d
Cleared May 29, 1981
NATAL-TEC HPL
K811370
Armkel, LLC
Chemistry · 15d
Cleared Nov 12, 1980
GESTE FOLLOW KIT DETERM. OF HPL
K802454
Syn-Kit, Inc.
Immunology · 35d
Cleared Oct 01, 1979
CENTRIA HPL RIA
K791854
Union Carbide Corp.
Chemistry · 12d
Cleared Sep 22, 1977
PROLACTIN RIA DIAG. KIT
K771656
Abbott Laboratories
Chemistry · 24d
Cleared May 20, 1977
RIALYZE HPL (RIA)
K770659
Miles Laboratories, Inc.
Immunology · 43d

About Product Code JMF - Regulatory Context