Medical Device Manufacturer · US , Los Osos , CA

More Diagnostics

16 submissions · 16 cleared · Since 1993
16
Total
16
Cleared
0
Denied

More Diagnostics — FDA 510(k) Submissions

More Diagnostics has submitted 16 FDA 510(k) premarket notifications since 1993, of which 16 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Single (specified) Analyte Controls (assayed And Unassayed), Multi-analyte Controls, All Kinds (assayed), Enzyme Controls (assayed And Unassayed), Drug Specific Control Materials, Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control . Use the specialty filter in the sidebar to narrow results.

16 devices
1–16 of 16
MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL
K072257 · LAS Drug Specific Control... · Toxicology
Jan 2008 170d
RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4
K050125 · JJY Multi-analyte Controls,... · Toxicology
Mar 2005 58d
CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3
K982845 · JJT Enzyme Controls (assayed... · Chemistry
Aug 1998 9d
IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT (WHOLE BLOOS) CONTROL, LEVEL 2, 250-2, IMMUN\S
K980331 · DIF Drug Mixture Control... · Toxicology
Mar 1998 47d
CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVEL
K972976 · JJT Enzyme Controls (assayed... · Chemistry
Aug 1997 18d
LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4
K970778 · JJX Single (specified)... · Chemistry
Apr 1997 44d
FIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3
K946193 · GIL Plasma, Fibrinogen Control · Hematology
Aug 1995 247d
MULTI-LEVEL CONTROL FOR FIBRIN DEGRADATION PRODUCTS
K943571 · DAP Fibrinogen And Fibrin... · Hematology
Jun 1995 331d
SERUM BILIRUBIN CONTROL- LEVEL 1, 2 AND 3
K944999 · JJX Single (specified)... · Chemistry
Jun 1995 236d
SERUM VOLATILES CONTROL - LEVELS 1 AND 2
K941698 · JJY Multi-analyte Controls,... · Chemistry
Jul 1994 113d
WHOLE BLOOD VOLATILES CONTROL, LEVELS 1 AND 2
K941876 · JJY Multi-analyte Controls,... · Chemistry
Jul 1994 101d
FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2
K932657 · DAP Fibrinogen And Fibrin... · Hematology
Nov 1993 153d
LD-1 ISOENZYME CONTROL (HUMAN) LEVEL 1 & 2
K932660 · JJX Single (specified)... · Chemistry
Oct 1993 148d
CKMB ISOENZYME CONTROL(HUMAN) LEVEL 1,2,& 3
K932658 · JJX Single (specified)... · Chemistry
Jul 1993 56d
MULTI LEVEL CONTROL FOR CKMB ISOENSYME IN SYRUM
K932659 · JJX Single (specified)... · Chemistry
Jul 1993 56d
CYCLOSPORINE (WHOLE BLOOD) CONTROL-PEDIATRIC LEVEL
K932662 · LAS Drug Specific Control... · Toxicology
Jul 1993 54d
Filters