Data / Medical devices / United States / Derby supply chain solutions
Derby supply chain solutions: FDA-registered device maker in Cleveland, TN, United States, 4 510(k) clearances
Derby supply chain solutions is registered with the FDA (registration 2000007960) in Cleveland, TN, United States. It lists 9 device types. The FDA files 4 510(k) clearances under its listings, the newest dated February 28, 2005. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2000007960
- Address
- 3285 Davy Crockett Dr., Cleveland, TN, United States, 37323
- Owner or operator
- Derby Industries, LLC (10026511)
- Roles
- Repackager or relabeler
- First device listed
- May 1, 2009
- Registered through
- 2026
- Brand names listed
- Accutest
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Antigens, All Groups, Streptococcus Spp. | GTY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Enzyme Immunoassay, Amphetamine | DKZ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Enzyme Immunoassay, Cannabinoids | LDJ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | 2 | Repackager or relabeler | accessdata.fda.gov |
| Enzyme Immunoassay, Opiates | DJG | 2 | Repackager or relabeler | accessdata.fda.gov |
| Enzyme Immunoassay, Phencyclidine | LCM | U | Repackager or relabeler | accessdata.fda.gov |
| Gas Chromatography, Methamphetamine | LAF | 2 | Repackager or relabeler | accessdata.fda.gov |
| Helicobacter Pylori | LYR | 1 | Repackager or relabeler | accessdata.fda.gov |
| System, Test, Infectious Mononucleosis | KTN | 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 |
|---|---|---|---|---|---|---|
| February 28, 2005 | K042272 | ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA) | KTN | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| July 14, 2003 | K031784 | ACON STREP A RAPID TEST DEVICE | GTY | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| April 2, 2003 | K024350 | ACON H. PYLORI RAPID TEST STRIP AND ACON H. PYLORI RAPID TEST DEVICE | LYR | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| May 8, 2002 | K020313 | ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD; ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE | DKZ | Substantially Equivalent | Acon Laboratories Co. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Test, Infectious Mononucleosis
- All makers of Antigens, All Groups, Streptococcus Spp.
- All makers of Helicobacter Pylori
- All makers of Enzyme Immunoassay, Cannabinoids
- All makers of Enzyme Immunoassay, Cocaine And Cocaine Metabolites
- All makers of Gas Chromatography, Methamphetamine
Updated February 28, 2005. 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.