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510(k) K120014

STA- COAG CONTROL (N+ABN) PLUS by Diagnostica Stago, Inc. — Product Code GGN

K120014 is an FDA 510(k) premarket notification submitted by Diagnostica Stago, Inc. for the device "STA- COAG CONTROL (N+ABN) PLUS". The FDA issued a decision of Substantially Equivalent on March 14, 2013. The device falls under product code GGN (Plasma, Coagulation Control), a Class II device regulated under 21 CFR 864.5425. Diagnostica Stago, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2013
Date Received
December 29, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plasma, Coagulation Control
Device Class
Class II
Regulation Number
864.5425
Review Panel
HE
Submission Type

Other clearances by Diagnostica Stago, Inc.

  • K253658 — STA Satellite Max® (April 27, 2026)
  • K212183 — STA R Max 3, STA Compact Max 3 (June 7, 2023)
  • K211485 — STA- NeoPTimal (December 23, 2022)
  • K162227 — STA® - Liatest® D-Di (December 10, 2016)
  • K151867 — STA R MAX (August 7, 2015)
  • K141144 — STA LIATEST D-DI (September 3, 2014)
  • K111822 — STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / (October 26, 2011)
  • K092937 — STA-HYBRID HEP CALIBRATOR (August 2, 2010)
  • K092170 — STA LIATEST FREE PS (December 22, 2009)
  • K093167 — STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER (December 22, 2009)

Other clearances for product code GGN

  • K170864 — VALIDATE D-Dimer Calibration Verification / Linearity Test Kit (June 21, 2017)
  • K163498 — VALIDATE Heparin Calibration Verification/Linearity Test Kit (March 16, 2017)
  • K161316 — George King Coumadin Plasma (February 23, 2017)
  • K162705 — VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit (January 5, 2017)
  • K152961 — VALIDATE D-Dimer Calibration Verification/Linearity Test Kit (June 3, 2016)
  • K150144 — VisuCon-F Low Fibrinogen Control Plasma (March 6, 2016)
  • K142132 — POOL NORM (December 12, 2014)
  • K133582 — HEMOSIL D-DIMER HS 500 CONTROL (August 15, 2014)
  • K120977 — DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DI (July 3, 2013)
  • K120900 — I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2 (May 31, 2013)

FDA data resources