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510(k) K984122

WAKO L-TYPE UIBC, WAKO UIBC CALIBRATOR by Wako Chemicals USA, Inc. — Product Code JQF

K984122 is an FDA 510(k) premarket notification submitted by Wako Chemicals USA, Inc. for the device "WAKO L-TYPE UIBC, WAKO UIBC CALIBRATOR". The FDA issued a decision of Substantially Equivalent on January 20, 1999. The device falls under product code JQF (Bathophenanthroline, Iron Binding Capacity), a Class I device regulated under 21 CFR 862.1415. Wako Chemicals USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 1999
Date Received
November 18, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bathophenanthroline, Iron Binding Capacity
Device Class
Class I
Regulation Number
862.1415
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 JQF

  • K051111 — SENTINEL UIBC LIQUID (November 17, 2005)
  • K875176 — WAKO(TM) UIBC (February 2, 1988)
  • K863066 — TRANSFERMETER (December 4, 1986)
  • K830032 — TOTAL IRON BINDING CAPACITY TEST (January 28, 1983)
  • K811942 — J & S IRON SATURATING REAGENT (September 8, 1981)
  • K810086 — IRON & TICB (January 28, 1981)
  • K792409 — ELVI TOTAL IRON BINDING CAPACITY (December 6, 1979)

FDA data resources