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510(k) K905643

BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY by Agen Biomedical , Ltd. — Product Code GHH

K905643 is an FDA 510(k) premarket notification submitted by Agen Biomedical , Ltd. for the device "BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY". The FDA issued a decision of Substantially Equivalent on April 12, 1991. The device falls under product code GHH (Fibrin Split Products), a Class II device regulated under 21 CFR 864.7320. Agen Biomedical , Ltd. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 1991
Date Received
December 17, 1990
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 Agen Biomedical , Ltd.

  • K993276 — SIMPLIFY D-DIMER, MODEL DCGK1 (December 14, 1999)
  • K974596 — DIMERTEST LATEX ASSAY (May 26, 1998)
  • K945642 — AGEN DIMERTEST GOLD EIA (October 25, 1995)
  • K890189 — AGEN DIMERTEST EIA (March 3, 1989)
  • K882944 — DIMERTEST(R) LATEX (August 17, 1988)

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)
  • K972316 — OPUS D-DIMER (September 9, 1997)

FDA data resources