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510(k) K010332

WAKO IMMUNOASSAY CALIBRATOR SET by Wako Chemicals USA, Inc. — Product Code JIT

K010332 is an FDA 510(k) premarket notification submitted by Wako Chemicals USA, Inc. for the device "WAKO IMMUNOASSAY CALIBRATOR SET". The FDA issued a decision of Substantially Equivalent on August 1, 2001. The device falls under product code JIT (Calibrator, Secondary), 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
August 1, 2001
Date Received
February 2, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Secondary
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 JIT

  • K171168 — VITROS Immunodiagnostic Products Insulin Calibrators (May 16, 2017)
  • K170938 — CalSet IGF-1 (April 26, 2017)
  • K170160 — Abbott ARCHITECT Free T3 (February 15, 2017)
  • K163534 — Lumipulse G FSH-N Calibrators (January 13, 2017)
  • K163546 — Lumipulse G Progesterone-N Calibrators (January 13, 2017)
  • K163521 — Lumipulse G LH Calibrators (January 12, 2017)
  • K163544 — Lumipulse G Prolactin (January 12, 2017)
  • K163078 — DC-UIBC-CAL (December 8, 2016)
  • K163053 — Lumipulse G E2-III Calibrators (December 1, 2016)
  • K162538 — ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Cal (November 17, 2016)

FDA data resources