Medical Device Manufacturer · FI , Finland

Wallac OY

22 submissions · 21 cleared · Since 1992
22
Total
21
Cleared
1
Denied

Wallac OY — FDA 510(k) Submissions

Wallac OY has submitted 22 FDA 510(k) premarket notifications since 1992, of which 21 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Radioimmunoassay, 17-hydroxyprogesterone, Electrode, Ion-specific, Chloride, Radioimmunoassay, Testosterones And Dihydrotestosterone, System, Test, Biotinidase, Radioimmunoassay, Thyroid-stimulating Hormone . Use the specialty filter in the sidebar to narrow results.

22 devices
1–22 of 22
PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM
DEN140010 · PJI Severe Combined... · Pathology
Dec 2014 299d
GSP NEONATAL BIOTINIDASE KIT
K131284 · NAK System, Test, Biotinidase · Chemistry
Nov 2013 192d
GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U
K100682 · JLX Radioimmunoassay,... · Chemistry
Jul 2010 135d
AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT
K081922 · JLX Radioimmunoassay,... · Chemistry
Apr 2009 283d
NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B
K071649 · JIA Enzymatic Methods, Galactose · Chemistry
Aug 2008 416d
AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112
K070889 · CGZ Electrode, Ion-specific,... · Chemistry
Apr 2008 381d
RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367
K050709 · GKA Abnormal Hemoglobin... · Hematology
Mar 2006 355d
MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT
K050960 · JLX Radioimmunoassay,... · Chemistry
Jul 2005 84d
DELFIA NEONATAL 17A-OH-PROGESTERONE KIT
K042424 · JLX Radioimmunoassay,... · Chemistry
Sep 2004 22d
AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT
K042425 · JLX Radioimmunoassay,... · Chemistry
Sep 2004 22d
DELFIA NEONATAL IRT KIT, MODEL A005-110
K003664 · CGZ Electrode, Ion-specific,... · Chemistry
Feb 2001 78d
AUTODELFIA NEONATAL IRT KIT, MODEL B005-112
K003668 · CGZ Electrode, Ion-specific,... · Chemistry
Feb 2001 76d
DELFIA NEONATAL IRT KIT
K993697 · CGZ Electrode, Ion-specific,... · Chemistry
Jun 2000 220d
DELFIA NEONATAL THYROXINE KIT
K943416 · CDX Radioimmunoassay, Total... · Chemistry
Mar 1995 238d
AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KIT
K944490 · CGI Radioimmunoassay, Estriol · Toxicology
Dec 1994 87d
DELFIA SHBG KIT
K940449 · CDZ Radioimmunoassay,... · Chemistry
Sep 1994 217d
AUTO DELFIA
K935047 · KHO Fluorometer, For Clinical... · Chemistry
May 1994 214d
DELFIA TESTTOSTERONE KIT
K932951 · CDZ Radioimmunoassay,... · Chemistry
Aug 1993 47d
DELFIA CORTISOL KIT
K930732 · JFT Fluorometric, Cortisol · Chemistry
Jul 1993 166d
DELFIA(R) HGH KIT
K930484 · CFL Radioimmunoassay, Human... · Chemistry
May 1993 102d
DELFIA DIGOXIN KIT
K924594 · KXT Enzyme Immunoassay, Digoxin · Toxicology
Dec 1992 98d
DELFIA HTSH ULTRA KIT
K923401 · JLW Radioimmunoassay,... · Chemistry
Nov 1992 143d
Filters