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510(k) K890619

EDL ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT by Elite Diagnostic , Ltd. — Product Code GFO

K890619 is an FDA 510(k) premarket notification submitted by Elite Diagnostic , Ltd. for the device "EDL ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT". The FDA issued a decision of Substantially Equivalent on March 15, 1989. The device falls under product code GFO (Activated Partial Thromboplastin), a Class II device regulated under 21 CFR 864.7925. Elite Diagnostic , Ltd. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1989
Date Received
February 7, 1989
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 Elite Diagnostic , Ltd.

  • K891370 — EDL ONE-STAGE PROTHROMBIN TIME REAGENT (April 21, 1989)
  • K890859 — EDL GLOBAL ACTIVATED PARTIAL THROMBOPLASTIN TIME (April 21, 1989)
  • K891179 — EDL NORMAL COAGULATION CONTROL (April 10, 1989)
  • K891175 — EDL ABNORMAL COAGULATION CONTROL (April 10, 1989)

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