More Diagnostics Inc.
Los Osos, CA, US
MORE DIAGNOSTICS INC. appears in FDA device records in Los Osos, CA. FDA records list 16 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 16 510(k) clearances for More Diagnostics Inc. between 1993 and 2008. The busiest year on record is 1993, with 5. The most recent is 2008, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 5 |
| 1994 | 2 |
| 1995 | 3 |
| 1997 | 2 |
| 1998 | 2 |
| 2005 | 1 |
| 2008 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K072257 | MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL | LAS | Substantially Equivalent | |
| K050125 | RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4 | JJY | Substantially Equivalent | |
| K982845 | CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3 | JJT | Substantially Equivalent | |
| K980331 | IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT (WHOLE BLOOS) CONTROL, LEVEL 2, 250-2, IMMUN\S | DIF | Substantially Equivalent | |
| K972976 | CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVEL | JJT | Substantially Equivalent | |
| K970778 | LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4 | JJX | Substantially Equivalent | |
| K946193 | FIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3 | GIL | Substantially Equivalent | |
| K943571 | MULTI-LEVEL CONTROL FOR FIBRIN DEGRADATION PRODUCTS | DAP | Substantially Equivalent | |
| K944999 | SERUM BILIRUBIN CONTROL- LEVEL 1, 2 AND 3 | JJX | Substantially Equivalent | |
| K941876 | WHOLE BLOOD VOLATILES CONTROL, LEVELS 1 AND 2 | JJY | Substantially Equivalent | |
| K941698 | SERUM VOLATILES CONTROL - LEVELS 1 AND 2 | JJY | Substantially Equivalent | |
| K932657 | FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2 | DAP | Substantially Equivalent | |
| K932660 | LD-1 ISOENZYME CONTROL (HUMAN) LEVEL 1 & 2 | JJX | Substantially Equivalent | |
| K932659 | MULTI LEVEL CONTROL FOR CKMB ISOENSYME IN SYRUM | JJX | Substantially Equivalent | |
| K932658 | CKMB ISOENZYME CONTROL(HUMAN) LEVEL 1,2,& 3 | JJX | Substantially Equivalent | |
| K932662 | CYCLOSPORINE (WHOLE BLOOD) CONTROL-PEDIATRIC LEVEL | LAS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2085085 | 1000142648 | MORE DIAGNOSTICS INC. | 2020 11TH ST, Los Osos, CA 93402 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DIFDrug Mixture Control Materials
- LASDrug Specific Control Materials
- JJTEnzyme Controls (Assayed And Unassayed)
- DAPFibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- GILPlasma, Fibrinogen Control
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain