Data / Medical devices / United States / Diversified Synergies, LLC
Diversified Synergies, LLC: FDA-registered device maker in Detroit, MI, United States, 3 510(k) clearances
Diversified Synergies, LLC is registered with the FDA (registration 3023372670) in Detroit, MI, United States. It lists 6 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 13, 2025. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3023372670
- Address
- 201 Waterman St, Detroit, MI, United States, 48209
- Owner or operator
- Diversified Chemical Technologies (10083482)
- Roles
- Repackager or relabeler
- First device listed
- November 23, 2021
- Registered through
- 2026
- Brand names listed
- BinaxNOW, BinaxNOW COVID-19/Flu A&B Combo Self Test 2T, BinaxNOW COVID-19/Flu A&B Combo Self Test 4T, ID NOW COVID-19 2, ID NOW Influenza A&B 2
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Coronavirus Antigen Detection Test System. | QKP | N | Repackager or relabeler | accessdata.fda.gov |
| Influenza A And Influenza B Multiplex Nucleic Acid Assay | OZE | 2 | Repackager or relabeler | accessdata.fda.gov |
| Multi-Analyte Respiratory Virus Antigen Detection Test | SCA | 2 | Repackager or relabeler | accessdata.fda.gov |
| Real Time Nucleic Acid Amplification System | OOI | 2 | Repackager or relabeler | accessdata.fda.gov |
| Respiratory Virus Panel Nucleic Acid Assay System | OCC | 2 | Repackager or relabeler | accessdata.fda.gov |
| Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings | QWR | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 13, 2025 | K243262 | QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test | SCA | Substantially Equivalent | Osang, LLC | accessdata.fda.gov |
| October 10, 2023 | K232775 | ID NOW Influenza A & B 2 | OCC | Substantially Equivalent | Abbott Diagnostics Scarborough, Inc. | accessdata.fda.gov |
| August 10, 2023 | K221925 | ID NOW COVID-19 2.0 | QWR | Substantially Equivalent | Abbott Diagnostics Scarborough, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Respiratory Virus Panel Nucleic Acid Assay System
- All makers of Real Time Nucleic Acid Amplification System
- All makers of Influenza A And Influenza B Multiplex Nucleic Acid Assay
- All makers of Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings
- All makers of Multi-Analyte Respiratory Virus Antigen Detection Test
- All makers of Coronavirus Antigen Detection Test System.
Updated January 13, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.