Dutchland Laboratories, Inc.: FDA filings under this applicant name
FDA lists 75 510(k) clearances under the applicant name “Dutchland Laboratories, Inc.” (first 1981, latest 1982), across 12 product codes in 3 review panels. Median 510(k) review time under this name: 20 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 |
|---|---|---|---|
| KIT | Media And Components, Synthetic Cell And Tissue Culture | 42 | 42 |
| KIS | Sera, Animal And Human | 9 | 9 |
| LHT | Staphylococcus Aureus Somatic Antigens | 7 | 7 |
| KIP | Formulations, Balanced Salt Solutions | 6 | 6 |
| KTQ | Reagent, Complement | 3 | 3 |
| LHW | Erythrocyte Suspension, Multi Species, Serological Reagent And Equipment | 2 | 2 |
| GQR | Antigens, Ha (Including Ha Control), Parainfluenza Virus 1-4 | 1 | 1 |
| JCC | Ph Buffer | 1 | 1 |
| JSK | Supplement, Culture Media | 1 | 1 |
| JTL | Plasma, Coagulase, Human, Horse And Rabbit | 1 | 1 |
Plus 2 more product codes.
Review panels
- Pathology (59)
- Microbiology (12)
- Immunology (3)
Most recent Dutchland Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K821919 | POWDERED RPMI-1634 MEDIUM | KIT | 1982-07-27 | 29 |
| K821918 | POWDERED RPMI-1603 MEDIUM | KIT | 1982-07-27 | 29 |
| K821917 | WAYMOUTH'S POWDER MEDIUM | KIT | 1982-07-27 | 29 |
| K821916 | IMPROVED MEM-RICHTER'S POWDER MODIF. | KIT | 1982-07-27 | 29 |
| K821915 | BME AUTOCLAVABLE MEDIUM | KIT | 1982-07-27 | 29 |
| K821914 | COON'S F-12 POWDER MEDIUM | KIT | 1982-07-27 | 29 |
| K821913 | ISCOVE'S MODIFIED DULBECCO POWDER MEDIUM | KIT | 1982-07-27 | 29 |
| K821912 | MCCOY'S POWDER MEDIUM 5A SUSPENSION | KIT | 1982-07-27 | 29 |
| K821911 | S-MEM-JOKLIK'S POWDER | KIT | 1982-07-27 | 29 |
| K820931 | HANK'S 199 POWDERED MEDIUM | KIT | 1982-04-21 | 20 |
65 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Dutchland Laboratories, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Dutchland Laboratories, Inc.?
FDA lists 75 510(k) clearances under the applicant name “Dutchland Laboratories, Inc.” (first 1981, latest 1982), across 12 product codes in 3 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 Dutchland Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dutchland Laboratories, Inc. is 20 days.
Which FDA product codes appear under Dutchland Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are KIT (Media And Components, Synthetic Cell And Tissue Culture, 42); KIS (Sera, Animal And Human, 9); LHT (Staphylococcus Aureus Somatic Antigens, 7).
Next steps
- See all 75 Dutchland Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KIT, Dutchland Laboratories, 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, 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.