Derma Media Lab., Inc.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Derma Media Lab., Inc.” (first 1996, latest 1997), across 18 product codes in 1 review panel. Median 510(k) review time under this name: 82 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 | 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 |
|---|---|---|---|
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 | 1 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 | 1 |
| CFR | Hexokinase, Glucose | 1 | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | 1 |
| CIC | Cresolphthalein Complexone, Calcium | 1 | 1 |
| CIG | Diazo Colorimetry, Bilirubin | 1 | 1 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 1 | 1 |
Plus 8 more product codes.
Review panels
- Clinical Chemistry (18)
Most recent Derma Media Lab., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K971309 | UREA | CDQ | 1997-08-01 | 115 |
| K970664 | GLUCOSE REAGENT | CFR | 1997-08-01 | 161 |
| K971072 | CHOLESTEROL REAGENT | CHH | 1997-06-20 | 88 |
| K971005 | TRIGLYCERIDES | JGY | 1997-04-21 | 33 |
| K970867 | URIC ACID REAGENT | KNK | 1997-04-21 | 42 |
| K964915 | MAGNESIUM | JGJ | 1997-03-26 | 107 |
| K964913 | IRON REAGENT | JIY | 1997-02-20 | 73 |
| K965134 | ALT/SGPT | CKA | 1997-02-18 | 57 |
| K964914 | ALKALINE PHOSPHATASE | CJE | 1997-02-04 | 57 |
| K965126 | AST/SGOT | CIT | 1997-01-17 | 25 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Derma Media Lab., Inc..
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.
- Derma Sciences, Inc. (22 510(k)s)
- Derma-Lase Co. (5 510(k)s)
- Derma Sciences Canada, Inc. (3 510(k)s)
- Derma Care Plus Products, LLC (2 510(k)s)
- Derma-Lock Medical Corp. (2 510(k)s)
- Derma-Safe Co. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Derma Media Lab., Inc.?
FDA lists 18 510(k) clearances under the applicant name “Derma Media Lab., Inc.” (first 1996, latest 1997), across 18 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Derma Media Lab., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Derma Media Lab., Inc. is 82 days.
Which FDA product codes appear under Derma Media Lab., Inc.?
The most frequent FDA product codes under this applicant name are CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen, 1); CEK (Biuret (Colorimetric), Total Protein, 1); CEO (Phosphomolybdate (Colorimetric), Inorganic Phosphorus, 1).
Next steps
- See all 18 Derma Media Lab., Inc. clearances with predicates and recalls
- Run predicate analysis for product code CDQ, Derma Media Lab., Inc.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.