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510(k) K053111

STA-CEPHASCREEN KIT by Diagnostica Stago, Inc. — Product Code GFO

K053111 is an FDA 510(k) premarket notification submitted by Diagnostica Stago, Inc. for the device "STA-CEPHASCREEN KIT". The FDA issued a decision of Substantially Equivalent on May 4, 2006. The device falls under product code GFO (Activated Partial Thromboplastin), a Class II device regulated under 21 CFR 864.7925. Diagnostica Stago, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2006
Date Received
November 4, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Activated Partial Thromboplastin
Device Class
Class II
Regulation Number
864.7925
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)
  • K120014 — STA- COAG CONTROL (N+ABN) PLUS (March 14, 2013)
  • 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)
  • K093167 — STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER (December 22, 2009)

Other clearances for product code GFO

  • K253957 — HemosIL Silica Clotting Time (January 9, 2026)
  • K193556 — Cryocheck Hex LA (October 23, 2020)
  • K160445 — HemosIL Silica Clotting Time (March 16, 2016)
  • K060688 — HEMOSIL SYNTHASIL (April 13, 2006)
  • K050221 — HEMOSIL SILICA CLOTTING TIME (March 30, 2005)
  • K022021 — VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT (November 1, 2002)
  • K014028 — CARESIDE APTT (February 8, 2002)
  • K014008 — HEMOCHRON JR. CITRATE APTT CUVETTE (January 24, 2002)
  • K992712 — SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334 (December 6, 1999)
  • K992711 — SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094 (December 6, 1999)

FDA data resources