JHN · Class I · 21 CFR 862.1475

FDA Product Code JHN: Turbidimetric Method, Lipoproteins

Leading manufacturers include Sigma Diagnostics, Inc., Randox Laboratories, Ltd. and Olympus America, Inc..

7
Total
7
Cleared
191d
Avg days
1994
Since

FDA 510(k) Cleared Turbidimetric Method, Lipoproteins Devices (Product Code JHN)

7 devices
1–7 of 7
Cleared Sep 15, 1995
APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC KIT
K950382
Randox Laboratories, Ltd.
Chemistry · 227d
Cleared Sep 15, 1995
APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KIT
K950383
Randox Laboratories, Ltd.
Chemistry · 227d
Cleared Sep 08, 1995
WAKO AUTOKIT APO A1
K952615
Wako Chemicals USA, Inc.
Immunology · 94d
Cleared Jul 05, 1995
OLYMPUS APOLIPOPROTEIN A1 IMMUNOTURBIDIMETRIC REAGENT
K952425
Olympus America, Inc.
Immunology · 42d
Cleared Jun 05, 1995
OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENT
K952466
Olympus America, Inc.
Immunology · 10d
Cleared Jun 02, 1994
APOLIPOPROTIEN B (APO B)
K932603
Sigma Diagnostics, Inc.
Chemistry · 370d
Cleared Jun 02, 1994
APOLIPOPROTIEN A-1 (APO A-1)
K932606
Sigma Diagnostics, Inc.
Chemistry · 370d

About Product Code JHN - Regulatory Context