Home / 510(k) Clearances / K973055

510(k) K973055

WAKO CH50 LINEARITY SET by Wako Chemicals USA, Inc. — Product Code JIW

K973055 is an FDA 510(k) premarket notification submitted by Wako Chemicals USA, Inc. for the device "WAKO CH50 LINEARITY SET". The FDA issued a decision of Substantially Equivalent on September 25, 1997. The device falls under product code JIW (Calibrator, Surrogate), a Class II device regulated under 21 CFR 862.1150. Wako Chemicals USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1997
Date Received
August 15, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Surrogate
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
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 JIW

  • K970396 — HUMAN CHORIONIC GONADOTROPIN CALIBRATOR (February 20, 1997)
  • K910255 — FLOW CYTOMETRY FITC/PE COMPENSATION KIT (April 3, 1991)
  • K902575 — SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL) (October 4, 1990)
  • K902294 — ACCUSCAN MICROBEAD STANDARDS (July 3, 1990)
  • K892213 — ACS COLLOID OSMOTIC PRESSURE CALIBRATOR (June 21, 1989)
  • K883389 — RAICHEM(TM) BILIRUBIN CONJUGATE STANDARD (December 14, 1988)
  • K882220 — CALIBRATION KIT (August 2, 1988)
  • K880654 — AMRESCO LIQUIZYME GLUCOSE/BUN STANDARD 0124, 0200 (June 7, 1988)
  • K880610 — UNIMETER CALIBRATION KIT (March 24, 1988)
  • K854028 — AUDIT AUTOMATED BLOOD CHEMISTRY ANALYZER (December 2, 1985)

FDA data resources