Data / Medical devices / United States / More Diagnostics Inc.
More Diagnostics Inc.: FDA-registered device maker in Los Osos, CA, United States, 4 510(k) clearances
More Diagnostics Inc. is registered with the FDA (registration 2085085) in Los Osos, CA, United States. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated January 30, 2008. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2085085
- FEI number
- 1000142648
- Address
- 2020 11TH ST, Los Osos, CA, United States, 93402
- Owner or operator
- MORE DIAGNOSTICS INC. (9009779)
- Roles
- Manufacturer
- First device listed
- October 10, 2007
- Registered through
- 2026
- Brand names listed
- CARDIAC MARKERS CONTROLS, Clinical Cardiac Control, Cyclosporine C2 Control, Ev/Rap/Tac/CsA, Ev/Tac/CsA Control, MPA CONTROLS, RAP/TAC/CSA CONTROLS, Rap/Tac/CsA Control and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Drug Specific Control Materials | LAS | 1 | Manufacturer | accessdata.fda.gov |
| Enzyme Controls (Assayed And Unassayed) | JJT | 1 | Manufacturer | accessdata.fda.gov |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | 1 | Manufacturer | 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 30, 2008 | K072257 | MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL | LAS | Substantially Equivalent | More Diagnostics | accessdata.fda.gov |
| March 18, 2005 | K050125 | RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4 | JJY | Substantially Equivalent | More Diagnostics | accessdata.fda.gov |
| August 29, 1997 | K972976 | CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVEL | JJT | Substantially Equivalent | More Diagnostics | accessdata.fda.gov |
| July 26, 1993 | K932662 | CYCLOSPORINE (WHOLE BLOOD) CONTROL-PEDIATRIC LEVEL | LAS | Substantially Equivalent | More Diagnostics | accessdata.fda.gov |
Compare with other makers
- All makers of Multi-Analyte Controls, All Kinds (Assayed)
- All makers of Enzyme Controls (Assayed And Unassayed)
- All makers of Drug Specific Control Materials
Updated January 30, 2008. 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.