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510(k) K781104

PLASMA COAGULATION CONT., ABNORMAL by Ortho Diagnostics, Inc. — Product Code GFO

K781104 is an FDA 510(k) premarket notification submitted by Ortho Diagnostics, Inc. for the device "PLASMA COAGULATION CONT., ABNORMAL". The FDA issued a decision of Substantially Equivalent on August 10, 1978. The device falls under product code GFO (Activated Partial Thromboplastin), a Class II device regulated under 21 CFR 864.7925. Ortho Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1978
Date Received
July 3, 1978
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 Ortho Diagnostics, Inc.

  • K802404 — ORTHO BOVINE ALBUMIN SOLUTION 30% PROTE (October 23, 1980)
  • K801507 — ANTIGEN CONTROL CELLS (August 20, 1980)
  • K800357 — BI-LEVEL ASSAYED CARD. DRUG CONT., I,II (April 16, 1980)
  • K800310 — ORTHO ANTISERA CONTROL (March 5, 1980)
  • K791791 — ORTHO ANTIBODY ENHANCEMENT SOLUTION (October 11, 1979)
  • K791301 — ORTHO TSH RIA KIT (September 24, 1979)
  • K790813 — MULTECON BLOOD GAS CONTROL (June 28, 1979)
  • K782063 — PREGNANCY, SENSIDEX TUBE TEST (April 4, 1979)
  • K782166 — SLIDE TEST FOR PREGNANCY, GRAVINDEX 90 (April 4, 1979)
  • K781638 — RUBINDEX*DIRECT SYSTEM (December 20, 1978)

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