Sun Biomedical Laboratories, Inc.: FDA clearances and approvals
Sun Biomedical Laboratories, Inc. has 17 FDA 510(k) clearances (first 1994, latest 2003), across 9 product codes in 2 review panels. Median 510(k) review time: 95 days. openFDA lists 3 product recalls by a recalling firm named Sun Biomedical 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 |
|---|---|---|---|
| DKZ | Enzyme Immunoassay, Amphetamine | 3 | 3 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 3 | 3 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 2 | 2 |
| DIS | Enzyme Immunoassay, Barbiturate | 2 | 2 |
| DJR | Enzyme Immunoassay, Methadone | 2 | 2 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 2 | 2 |
| DJG | Enzyme Immunoassay, Opiates | 1 | 1 |
| JXM | Enzyme Immunoassay, Benzodiazepine | 1 | 1 |
| LCM | Enzyme Immunoassay, Phencyclidine | 1 | 1 |
Review panels
Most recent Sun Biomedical Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K023856 | VISUALINE METHADONE DIPSTRIPTEST | DJR | 2003-08-25 | 279 |
| K023648 | VISUALINE CUP IV FOR DRUGS OF ABUSE TEST FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPHETAMI | LDJ | 2003-05-06 | 188 |
| K014089 | VISUALINE II (ALSO KNOWN AS SUNLINE) BARITURATES | DIS | 2002-04-25 | 135 |
| K020136 | VISUALINE BARBITURATES DIPSTRIP TEST | DIS | 2002-03-20 | 64 |
| K011499 | VISUALINE AMPHETAMINE DIPSTRIP ASSAY | DKZ | 2001-07-17 | 63 |
| K010177 | VISUALINE II (ALSO KNOWN AS SUNLINE) AMPHETAMINE ASSAY | DKZ | 2001-05-17 | 119 |
| K993485 | VISUALINE V DRUGS OF ABUSE DIPSTRIP PANEL FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPE | DIO | 1999-12-27 | 74 |
| K983790 | VISUALINE II (ALSO KNOWN AS SUNLINE) PHENCYCLIDINE | LCM | 1999-03-01 | 125 |
| K981314 | VISUALINE II (ALSO KNOWN AS SUNLINE) METHADONE | DJR | 1998-09-04 | 147 |
| K972032 | VISUALINE II METHAMPHETIMINE | DKZ | 1997-08-12 | 71 |
7 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2008-05-28.
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 Sun Biomedical Laboratories, Inc. have?
Sun Biomedical Laboratories, Inc. has 17 FDA 510(k) clearances (first 1994, latest 2003), across 9 product codes in 2 review panels.
How long does FDA take to clear Sun Biomedical Laboratories, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Sun Biomedical Laboratories, Inc.'s cleared 510(k)s is 95 days.
What devices does Sun Biomedical Laboratories, Inc. make?
Its most frequent FDA product codes are DKZ (Enzyme Immunoassay, Amphetamine, 3); LDJ (Enzyme Immunoassay, Cannabinoids, 3); DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites, 2).
Has Sun Biomedical Laboratories, Inc. had device recalls?
openFDA lists 3 product recalls in 1 recall event by a recalling firm whose name matches Sun Biomedical Laboratories, Inc; the most recent began 2008-05-28. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 17 Sun Biomedical Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DKZ, Sun Biomedical 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.