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510(k) K954145

WAKO AUTOKIT CH50 by Wako Chemicals USA, Inc. — Product Code DAE

K954145 is an FDA 510(k) premarket notification submitted by Wako Chemicals USA, Inc. for the device "WAKO AUTOKIT CH50". The FDA issued a decision of Substantially Equivalent on December 18, 1995. The device falls under product code DAE (Complement C9, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5240. Wako Chemicals USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1995
Date Received
September 5, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Complement C9, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5240
Review Panel
IM
Submission Type

Other clearances by Wako Chemicals USA, Inc.

  • K100464 — UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, (February 23, 2011)
  • K080125 — APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 (July 18, 2008)
  • K080123 — APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201 (July 17, 2008)
  • K061775 — WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR (February 23, 2007)
  • K062368 — WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP (January 31, 2007)
  • K053132 — WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791 (December 30, 2005)
  • K053131 — WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191 (December 30, 2005)
  • DEN050002 — LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS (May 19, 2005)
  • K042551 — MULTI-CHEM CALIBRATOR A (November 16, 2004)
  • K042550 — MULTI-LIPID CALIBRATOR (November 8, 2004)

Other clearances for product code DAE

  • K150412 — Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator (August 28, 2015)
  • K113349 — HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR US (July 11, 2012)
  • K992488 — TOTAL HAEMOLYTIC COMPLEMENT RID KIT (September 17, 1999)
  • K974111 — QUIDEL CH50 EQ EIA (July 29, 1998)
  • K951639 — COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE) (October 13, 1995)

FDA data resources