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510(k) K002642

MINIQUANT D-DIMER, MODEL 1447 by Biopool Intl., Inc. — Product Code DAP

K002642 is an FDA 510(k) premarket notification submitted by Biopool Intl., Inc. for the device "MINIQUANT D-DIMER, MODEL 1447". The FDA issued a decision of Substantially Equivalent on February 5, 2001. 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. Biopool Intl., Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 2001
Date Received
August 24, 2000
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 Biopool Intl., Inc.

  • K983898 — BIOCLOT APC SENSITIVITY (January 6, 1999)
  • K981752 — I-STAT COAGULATION CONTROL SET (June 15, 1998)
  • K980314 — FETAL D TECTION KIT (April 8, 1998)

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