Medical Device Manufacturer · US , Parsippany , NJ

Diagnostica Stago, Inc.

15 submissions · 15 cleared · Since 2001
15
Total
15
Cleared
0
Denied

Diagnostica Stago, Inc. — FDA 510(k) Submissions

Diagnostica Stago, Inc. has submitted 15 FDA 510(k) premarket notifications since 2001, of which 15 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Multipurpose For In Vitro Coagulation Studies, Plasma, Coagulation Control, Test, Qualitative And Quantitative Factor Deficiency, Reagent, Russel Viper Venom, Calibrator, Multi-analyte Mixture . Use the specialty filter in the sidebar to narrow results.

15 devices
1–15 of 15
STA- COAG CONTROL (N+ABN) PLUS
K120014 · GGN Plasma, Coagulation Control · Hematology
Mar 2013 441d
STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH
K111822 · KFF Assay, Heparin · Hematology
Oct 2011 120d
STA-HYBRID HEP CALIBRATOR
K092937 · JIT Calibrator, Secondary · Hematology
Aug 2010 312d
STA LIATEST FREE PS
K092170 · GGP Test, Qualitative And... · Hematology
Dec 2009 154d
STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER
K093167 · JPA System, Multipurpose For... · Hematology
Dec 2009 76d
STA - FREE PS CALIBRATOR
K092113 · JIX Calibrator, Multi-analyte... · Hematology
Nov 2009 122d
STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER
K082248 · JPA System, Multipurpose For... · Hematology
Dec 2008 126d
STA-R EVOLUTION AUTOMATED MULTI-PARAMETRIC ANALYZER
K082675 · JPA System, Multipurpose For... · Hematology
Oct 2008 25d
STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM
K061805 · GIR Reagent, Russel Viper Venom · Hematology
Dec 2006 162d
STA - CONTROL LA 1+2
K061803 · GGC Control, Plasma, Abnormal · Hematology
Jul 2006 31d
STA-CEPHASCREEN KIT
K053111 · GFO Activated Partial... · Hematology
May 2006 181d
STA-LIATEST FREE PROTEIN S TEST KIT
K010963 · GGP Test, Qualitative And... · Hematology
Jun 2001 68d
STA-QUALITY HBPM/LMWH KIT
K010324 · GGN Plasma, Coagulation Control · Hematology
Apr 2001 66d
STA -CALIBRATOR HBPM/LMWH KIT
K010350 · GGN Plasma, Coagulation Control · Hematology
Apr 2001 63d
ASSERACHROM HPIA TEST KIT
K003767 · LCO Platelet Factor 4... · Hematology
Feb 2001 68d
Filters
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