Company ยท FI
Wallac OY
FDA 510(k) clearances and medical device recalls filed under this name, 1992 to 2014. Name variants (Inc, Corp, punctuation) are merged.
24510(k) clearances (0 in 12 months)
1recalls (1 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JLX | Radioimmunoassay, 17-Hydroxyprogesterone | 5 |
| CGZ | Electrode, Ion-Specific, Chloride | 4 |
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 2 |
| NAK | System, Test, Biotinidase | 2 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 |
| CFL | Radioimmunoassay, Human Growth Hormone | 1 |
| CGI | Radioimmunoassay, Estriol | 1 |
| GKA | Abnormal Hemoglobin Quantitation | 1 |
| JFT | Fluorometric, Cortisol | 1 |
| JIA | Enzymatic Methods, Galactose | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 |
| JNB | Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine | 1 |
| KHO | Fluorometer, For Clinical Use | 1 |
| KQP | Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase | 1 |
| KXT | Enzyme Immunoassay, Digoxin | 1 |
| PJI | Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 15, 2014 | DEN140010 | PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM Wallac OY | PJI |
| Nov 14, 2013 | K131284 | GSP NEONATAL BIOTINIDASE KIT Wallac OY | NAK |
| Jul 23, 2010 | K100682 | GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U Wallac OY | JLX |
| Apr 16, 2009 | K081922 | AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT Wallac OY, FI | JLX |
| Aug 7, 2008 | K071649 | NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B Wallac OY | JIA |
| Apr 14, 2008 | K070889 | AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112 Wallac OY, FI | CGZ |
| Mar 8, 2006 | K050709 | RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367 Wallac OY, FI | GKA |
| Jul 11, 2005 | K050960 | MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT Wallac OY, FI | JLX |
| Sep 30, 2004 | K042425 | AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT Wallac OY, FI | JLX |
| Sep 30, 2004 | K042424 | DELFIA NEONATAL 17A-OH-PROGESTERONE KIT Wallac OY, FI | JLX |
| Feb 14, 2001 | K003664 | DELFIA NEONATAL IRT KIT, MODEL A005-110 Wallac OY, FI | CGZ |
| Feb 12, 2001 | K003668 | AUTODELFIA NEONATAL IRT KIT, MODEL B005-112 Wallac OY, FI | CGZ |
| Jun 9, 2000 | K993697 | DELFIA NEONATAL IRT KIT Wallac OY, FI | CGZ |
| Feb 15, 2000 | DEN990008 | WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-4000 Wallac, Inc. | NAK |
| Feb 2, 1999 | K982307 | WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000 Wallac, Inc. | JNB |
| Mar 10, 1995 | K943416 | DELFIA NEONATAL THYROXINE KIT Wallac OY, FI | CDX |
| Dec 9, 1994 | K944490 | AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KIT Wallac OY, FI | CGI |
| Sep 6, 1994 | K940449 | DELFIA SHBG KIT Wallac OY, FI | CDZ |
| May 23, 1994 | K935047 | AUTO DELFIA Wallac OY, FI | KHO |
| Aug 3, 1993 | K932951 | DELFIA TESTTOSTERONE KIT Wallac OY, FI | CDZ |
| Jul 27, 1993 | K930732 | DELFIA CORTISOL KIT Wallac OY, FI | JFT |
| May 11, 1993 | K930484 | DELFIA(R) HGH KIT Wallac OY, FI | CFL |
| Dec 17, 1992 | K924594 | DELFIA DIGOXIN KIT Wallac OY, FI | KXT |
| Nov 30, 1992 | K923401 | DELFIA HTSH ULTRA KIT Wallac OY, FI | JLW |