WALLAC OY
FDA Regulatory Profile
WALLAC OY appears in FDA public data with 1 recall, 24 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2713-2026, Class II) was initiated on May 18, 2026. Its most recent 510(k) clearance was granted on December 15, 2014.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 24
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2713-2026 | Class II | GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used in FLUORE | May 18, 2026 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| DEN140010 | PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM | December 15, 2014 |
| K131284 | GSP NEONATAL BIOTINIDASE KIT | November 14, 2013 |
| K100682 | GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U | July 23, 2010 |
| K081922 | AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT | April 16, 2009 |
| K071649 | NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B | August 7, 2008 |
| K070889 | AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112 | April 14, 2008 |
| K050709 | RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367 | March 8, 2006 |
| K050960 | MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT | July 11, 2005 |
| K042425 | AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT | September 30, 2004 |
| K042424 | DELFIA NEONATAL 17A-OH-PROGESTERONE KIT | September 30, 2004 |
| K003664 | DELFIA NEONATAL IRT KIT, MODEL A005-110 | February 14, 2001 |
| K003668 | AUTODELFIA NEONATAL IRT KIT, MODEL B005-112 | February 12, 2001 |
| K993697 | DELFIA NEONATAL IRT KIT | June 9, 2000 |
| DEN990008 | WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-4000 | February 15, 2000 |
| K982307 | WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000 | February 2, 1999 |
| K943416 | DELFIA NEONATAL THYROXINE KIT | March 10, 1995 |
| K944490 | AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KIT | December 9, 1994 |
| K940449 | DELFIA SHBG KIT | September 6, 1994 |
| K935047 | AUTO DELFIA | May 23, 1994 |
| K932951 | DELFIA TESTTOSTERONE KIT | August 3, 1993 |