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510(k) K890189

AGEN DIMERTEST EIA by Agen Biomedical , Ltd. — Product Code DAP

K890189 is an FDA 510(k) premarket notification submitted by Agen Biomedical , Ltd. for the device "AGEN DIMERTEST EIA". The FDA issued a decision of Substantially Equivalent on March 3, 1989. The device falls under product code DAP (Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control), 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
March 3, 1989
Date Received
January 17, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
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)
  • K905643 — BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY (April 12, 1991)
  • K882944 — DIMERTEST(R) LATEX (August 17, 1988)

Other clearances for product code DAP

  • K172903 — HemosIL D-Dimer HS 500 (November 22, 2017)
  • K162227 — STA® - Liatest® D-Di (December 10, 2016)
  • K160885 — HemosIL D-Dimer HS (October 27, 2016)
  • K151534 — HemosIL D-Dimer HS (July 6, 2015)
  • K141144 — STA LIATEST D-DI (September 3, 2014)
  • K112818 — VIDAS D-DIMER EXCLUSION II (DEX2) (July 31, 2012)
  • K110303 — STRATUS CS ACUTE CARE D-DIMER (May 16, 2011)
  • K093626 — INNOVANCE D-DIMER, MODEL OPBP09 (November 29, 2010)
  • K090264 — HEMOSIL D-DIMER HS 500, CONTROLS (February 5, 2010)
  • K091916 — INNOVANCE D-DIMER, MODEL OPBP09 (October 29, 2009)

FDA data resources