Wallac OY: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Wallac OY” (first 1992, latest 2013), plus 1 De Novo decision, across 14 product codes in 4 review panels. Median 510(k) review time under this name: 143 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 192 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JLX | Radioimmunoassay, 17-Hydroxyprogesterone | 5 | 5 |
| CGZ | Electrode, Ion-Specific, Chloride | 4 | 4 |
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 2 | 2 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 | 1 |
| CFL | Radioimmunoassay, Human Growth Hormone | 1 | 1 |
| CGI | Radioimmunoassay, Estriol | 1 | 1 |
| GKA | Abnormal Hemoglobin Quantitation | 1 | 1 |
| JFT | Fluorometric, Cortisol | 1 | 1 |
| JIA | Enzymatic Methods, Galactose | 1 | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 | 1 |
Plus 4 more product codes.
Review panels
- Clinical Chemistry (19)
- Hematology (1)
- Immunology (1)
- Clinical Toxicology (1)
Most recent Wallac OY 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K131284 | GSP NEONATAL BIOTINIDASE KIT | NAK | 2013-11-14 | 192 |
| K100682 | GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U | JLX | 2010-07-23 | 135 |
| K081922 | AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT | JLX | 2009-04-16 | 283 |
| K071649 | NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B | JIA | 2008-08-07 | 416 |
| K070889 | AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112 | CGZ | 2008-04-14 | 381 |
| K050709 | RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367 | GKA | 2006-03-08 | 355 |
| K050960 | MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT | JLX | 2005-07-11 | 84 |
| K042425 | AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT | JLX | 2004-09-30 | 22 |
| K042424 | DELFIA NEONATAL 17A-OH-PROGESTERONE KIT | JLX | 2004-09-30 | 22 |
| K003664 | DELFIA NEONATAL IRT KIT, MODEL A005-110 | CGZ | 2001-02-14 | 78 |
11 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN140010 | De Novo | Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System | 2014-12-15 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2026-05-18.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Wallac Oy, A Subsidiary of Perkinelmer, Inc. (4 510(k)s)
- Wallac Oy, Subsidiary of Perkinelmer, Inc. (2 510(k)s)
- Wallac, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Wallac OY?
FDA lists 21 510(k) clearances under the applicant name “Wallac OY” (first 1992, latest 2013), plus 1 De Novo decision, across 14 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Wallac OY?
The median time from FDA receipt to decision across 510(k)s cleared under the name Wallac OY is 143 days.
Which FDA product codes appear under Wallac OY?
The most frequent FDA product codes under this applicant name are JLX (Radioimmunoassay, 17-Hydroxyprogesterone, 5); CGZ (Electrode, Ion-Specific, Chloride, 4); CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone, 2).
Next steps
- See all 21 Wallac OY clearances with predicates and recalls
- Run predicate analysis for product code JLX, Wallac OY's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.