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510(k) K921118

ACS APCT REAGENT by Analytical Control Systems, Inc. — Product Code GFO

K921118 is an FDA 510(k) premarket notification submitted by Analytical Control Systems, Inc. for the device "ACS APCT REAGENT". The FDA issued a decision of Substantially Equivalent on July 28, 1992. The device falls under product code GFO (Activated Partial Thromboplastin), a Class II device regulated under 21 CFR 864.7925. Analytical Control Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1992
Date Received
March 9, 1992
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 Analytical Control Systems, Inc.

  • K961892 — SPECKTIN-LA TEST SET (March 7, 1997)
  • K941115 — ACS CARDIO-TROL CONTROL (July 20, 1994)
  • K940272 — ACS NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL (April 20, 1994)
  • K940397 — ACS O DILVENT PROTEIN DILUTION MATRIX (March 11, 1994)
  • K930477 — ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATOR (June 7, 1993)
  • K926012 — ACS APCT REAGENT, MODIFIED (April 27, 1993)
  • K925340 — COAGULATION CONTROL CONTAINING HEMOGLOBIN (March 23, 1993)
  • K925906 — NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL (February 18, 1993)
  • K921223 — ACS FREEZE-DRIED APTT REAGENT (August 18, 1992)
  • K913249 — ACS ULTRA-1 THROMBOPLASTIN (December 4, 1991)

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)
  • K053111 — STA-CEPHASCREEN KIT (May 4, 2006)
  • 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)

FDA data resources