Home / 510(k) Clearances / K972316

510(k) K972316

OPUS D-DIMER by Behring Diagnostics, Inc. — Product Code GHH

K972316 is an FDA 510(k) premarket notification submitted by Behring Diagnostics, Inc. for the device "OPUS D-DIMER". The FDA issued a decision of Substantially Equivalent on September 9, 1997. The device falls under product code GHH (Fibrin Split Products), a Class II device regulated under 21 CFR 864.7320. Behring Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1997
Date Received
June 20, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fibrin Split Products
Device Class
Class II
Regulation Number
864.7320
Review Panel
HE
Submission Type

Other clearances by Behring Diagnostics, Inc.

  • K973832 — OPUS HLH CONTROLS (October 27, 1997)
  • K972929 — N ANTISERUM TO HUMAN ALBUMIN (October 20, 1997)
  • K972840 — N ANTISERUM TO HUMAN TRANSFERRIN (October 17, 1997)
  • K973202 — MODIFICATION OF OPUS FERRITIN TEST SYSTEM (September 12, 1997)
  • K972116 — VON WILLEBRAND REAGENT (July 25, 1997)
  • K972011 — OPUS ETHANOL (July 22, 1997)
  • K971596 — EMIT II OPIATES 300/2000 ASSAY (June 25, 1997)
  • K971600 — EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH) (June 25, 1997)
  • K964595 — OPUS PSA TEST SYSTEM (June 24, 1997)
  • K971725 — OPUS PROGESTERONE (June 18, 1997)

Other clearances for product code GHH

  • K112120 — DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET (January 24, 2013)
  • K072288 — PATHFAST D-DIMER (May 6, 2009)
  • K070453 — OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR30 (June 11, 2007)
  • K062203 — TINA-QUANT D-DIMER TEST SYSTEM (March 14, 2007)
  • K042890 — TRIAGE D-DIMER TEST, MODEL 98100 (November 29, 2004)
  • K030740 — MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM (April 1, 2003)
  • K021877 — MDA D-DIMER (August 7, 2002)
  • K011143 — TINA-QUANT D-DIMER TEST SYSTEM (May 29, 2001)
  • K993276 — SIMPLIFY D-DIMER, MODEL DCGK1 (December 14, 1999)
  • K945642 — AGEN DIMERTEST GOLD EIA (October 25, 1995)

FDA data resources