Medical Device Manufacturer · US , Parsippany , NJ

Diagnostica Stago, Inc. - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 2001

Recent clearances: STA Satellite Max®, STA- COAG CONTROL (N+ABN) PLUS, STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH

Official Website

16

Total

16

Cleared

0

Denied

FDA 510(k) Regulatory Record - Diagnostica Stago, Inc. Hematology ✕

16 devices

1-12 of 16

Cleared Apr 27, 2026

STA Satellite Max®

Hematology · 158d

Cleared Mar 14, 2013

STA- COAG CONTROL (N+ABN) PLUS

Hematology · 441d

Cleared Oct 26, 2011

STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY...

Hematology · 120d

Cleared Aug 02, 2010

STA-HYBRID HEP CALIBRATOR

Hematology · 312d

Cleared Dec 22, 2009

STA LIATEST FREE PS

Hematology · 154d

Cleared Dec 22, 2009

STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER

Hematology · 76d

Cleared Nov 13, 2009

STA - FREE PS CALIBRATOR

Hematology · 122d

Cleared Dec 12, 2008

STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER

Hematology · 126d

Cleared Oct 10, 2008

STA-R EVOLUTION AUTOMATED MULTI-PARAMETRIC ANALYZER

Hematology · 25d

Cleared Dec 06, 2006

STA - STACLOT DRVV SCREEN

Hematology · 162d

Cleared Jul 28, 2006

STA - CONTROL LA 1+2

Hematology · 31d

Cleared May 04, 2006

STA-CEPHASCREEN KIT

Hematology · 181d