Utak Laboratories, Inc.: FDA clearances and approvals
Utak Laboratories, Inc. has 23 FDA 510(k) clearances (first 1980, latest 1991), across 3 product codes in 2 review panels. Median 510(k) review time: 40 days. openFDA lists 1 product recall by a recalling firm named Utak Laboratories, Inc.
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 |
|---|---|---|---|
| DIF | Drug Mixture Control Materials | 13 | 13 |
| LAS | Drug Specific Control Materials | 8 | 8 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 2 | 2 |
Review panels
Most recent Utak Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K903061 | UTAK LABORATORIES TOXICOLOGY CONTROL | LAS | 1991-04-12 | 277 |
| K883147 | TRACE ELEMENTS SERUM TOXICOLOGY CONTROL | JJY | 1988-10-06 | 72 |
| K862419 | SERUM VANCOMYCIN TOXICOLOGY CONTROL | LAS | 1986-11-13 | 141 |
| K862418 | BENZODIAZEPINES TOXICOLOGY CONTROL | LAS | 1986-11-13 | 141 |
| K862421 | SERUM CLONAZEPAM TOXICOLOGY CONTROL | LAS | 1986-11-05 | 133 |
| K862420 | UTAK-STABBS TOXICOLOGY CONTROL | JJY | 1986-08-04 | 40 |
| K831736 | TRICYCLIC ANTIDEPRESSANTS | DIF | 1983-07-28 | 58 |
| K831741 | FLURAZEPAM TOXICOLOGY CONTROL | DIF | 1983-07-26 | 56 |
| K831738 | CAFFINE TOXICOLOGY CONTROL | LAS | 1983-07-26 | 56 |
| K831735 | MAPROTILINE | LAS | 1983-07-26 | 56 |
13 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2020-03-20.
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 Utak Laboratories, Inc. have?
Utak Laboratories, Inc. has 23 FDA 510(k) clearances (first 1980, latest 1991), across 3 product codes in 2 review panels.
How long does FDA take to clear Utak Laboratories, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Utak Laboratories, Inc.'s cleared 510(k)s is 40 days.
What devices does Utak Laboratories, Inc. make?
Its most frequent FDA product codes are DIF (Drug Mixture Control Materials, 13); LAS (Drug Specific Control Materials, 8); JJY (Multi-Analyte Controls, All Kinds (Assayed), 2).
Has Utak Laboratories, Inc. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Utak Laboratories, Inc; the most recent began 2020-03-20. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 23 Utak Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DIF, Utak Laboratories, 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.