Wallac, Inc.: FDA clearances and approvals
Wallac, Inc. has 1 FDA 510(k) clearance (first 1999, latest 1999), plus 1 De Novo decision, across 2 product codes in 1 review panel. Median 510(k) review time: 216 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 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 |
|---|---|---|---|
| JNB | Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine | 1 | 1 |
| NAK | System, Test, Biotinidase | 1 | 0 |
Review panels
Most recent Wallac, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K982307 | WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000 | JNB | 1999-02-02 | 216 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN990008 | De Novo | System, Test, Biotinidase | 2000-02-15 |
Recalls
openFDA lists no recalls under a recalling firm named Wallac, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Wallac, Inc. have?
Wallac, Inc. has 1 FDA 510(k) clearance (first 1999, latest 1999), plus 1 De Novo decision, across 2 product codes in 1 review panel.
How long does FDA take to clear Wallac, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Wallac, Inc.'s cleared 510(k)s is 216 days.
What devices does Wallac, Inc. make?
Its most frequent FDA product codes are JNB (Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine, 1); NAK (System, Test, Biotinidase, 1).
Has Wallac, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Wallac, Inc. Related entities may recall under other names.
Next steps
- See all 1 Wallac, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JNB, Wallac, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.