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510(k) K934326

MULTIFIBREN U by Behring Diagnostics, Inc. — Product Code KQJ

K934326 is an FDA 510(k) premarket notification submitted by Behring Diagnostics, Inc. for the device "MULTIFIBREN U". The FDA issued a decision of Substantially Equivalent on Apr 19, 1994. The device falls under product code KQJ (System, Fibrinogen Determination), a Class II device regulated under 21 CFR 864.7340. Behring Diagnostics, Inc. has 144 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 19, 1994
Date Received
Sep 3, 1993
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
510(k)

Other clearances by Behring Diagnostics, Inc.

  • K973832 — OPUS HLH CONTROLS (Oct 27, 1997)
  • K972929 — N ANTISERUM TO HUMAN ALBUMIN (Oct 20, 1997)
  • K972840 — N ANTISERUM TO HUMAN TRANSFERRIN (Oct 17, 1997)
  • K973202 — MODIFICATION OF OPUS FERRITIN TEST SYSTEM (Sep 12, 1997)
  • K972316 — OPUS D-DIMER (Sep 9, 1997)
  • K972116 — VON WILLEBRAND REAGENT (Jul 25, 1997)
  • K972011 — OPUS ETHANOL (Jul 22, 1997)
  • K971600 — EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH) (Jun 25, 1997)
  • K971596 — EMIT II OPIATES 300/2000 ASSAY (Jun 25, 1997)
  • K964595 — OPUS PSA TEST SYSTEM (Jun 24, 1997)

Other clearances for product code KQJ

  • K251968 — HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL (Jul 24, 2025)
  • K073367 — HEMOSIL FIBRINOGEN-C (Dec 27, 2007)
  • K050928 — DADE THROMBIN REAGENT (Jun 29, 2005)
  • K971858 — SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A) (Oct 9, 1997)
  • K970189 — FIF TM (May 21, 1997)
  • K965113 — N-ASSAY TIA FIBRINOGEN TEST KIT (Apr 16, 1997)
  • K931721 — IL TEST FIBRINOGEN-C (Aug 13, 1993)
  • K922416 — FIBRINOGEN RID TEST KIT (Mar 9, 1993)
  • K925988 — MULTIFIBREN (Mar 1, 1993)
  • K923593 — HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONT PLAS (Sep 22, 1992)

FDA data resources

Source: FDA 510(k) database entry for K934326. Report a data issue: hello@regdatalab.com.