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510(k) K841020

FIBRINOGEN ASSAY KIT by Helena Laboratories — Product Code KQJ

K841020 is an FDA 510(k) premarket notification submitted by Helena Laboratories for the device "FIBRINOGEN ASSAY KIT". The FDA issued a decision of Substantially Equivalent on May 2, 1984. The device falls under product code KQJ (System, Fibrinogen Determination), a Class II device regulated under 21 CFR 864.7340. Helena Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1984
Date Received
March 12, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Fibrinogen Determination
Device Class
Class II
Regulation Number
864.7340
Review Panel
HE
Submission Type

Other clearances by Helena Laboratories

  • K213396 — SPIFE A1AT kit (October 13, 2022)
  • K192931 — V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control (April 19, 2022)
  • K131479 — V8 SP NORMAL CONTROL, ABNORMAL CONTROL (October 7, 2013)
  • K100103 — SPECIALTY ASSAYED CONTROL-2 (December 15, 2010)
  • K061991 — PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA (February 23, 2007)
  • K061069 — SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, S (July 6, 2006)
  • K061014 — ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP (May 10, 2006)
  • K050053 — HEMORAM/AGGRAM ANALYZER (July 11, 2005)
  • K024162 — SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389 (February 19, 2003)
  • K023761 — PLATELETWORKS, MODELS PW-A, PW-C (February 14, 2003)

Other clearances for product code KQJ

  • K251968 — HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL (July 24, 2025)
  • K073367 — HEMOSIL FIBRINOGEN-C (December 27, 2007)
  • K050928 — DADE THROMBIN REAGENT (June 29, 2005)
  • K971858 — SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A) (October 9, 1997)
  • K970189 — FIF TM (May 21, 1997)
  • K965113 — N-ASSAY TIA FIBRINOGEN TEST KIT (April 16, 1997)
  • K934326 — MULTIFIBREN U (April 19, 1994)
  • K931721 — IL TEST FIBRINOGEN-C (August 13, 1993)
  • K922416 — FIBRINOGEN RID TEST KIT (March 9, 1993)
  • K925988 — MULTIFIBREN (March 1, 1993)

FDA data resources