Home / 510(k) Clearances / K842847

510(k) K842847

WAKO AUTOMATED REAGENTS FOR HITACHI 705 by Wako Chemicals USA, Inc. — Product Code CJW

K842847 is an FDA 510(k) premarket notification submitted by Wako Chemicals USA, Inc. for the device "WAKO AUTOMATED REAGENTS FOR HITACHI 705". The FDA issued a decision of Substantially Equivalent on December 11, 1984. The device falls under product code CJW (Bromcresol Purple Dye-Binding, Albumin), a Class II device regulated under 21 CFR 862.1035. Wako Chemicals USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1984
Date Received
July 20, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bromcresol Purple Dye-Binding, Albumin
Device Class
Class II
Regulation Number
862.1035
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)
  • K042549 — MULTI CHEM CAL B (November 8, 2004)

Other clearances for product code CJW

  • K203530 — Albumin BCP2 (March 18, 2022)
  • K193001 — Albumin BCP (December 19, 2019)
  • K132664 — ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRAT (October 16, 2013)
  • K021636 — ALBUMIN REAGENT (July 17, 2002)
  • K000483 — RANDOX ALBUMIN (March 31, 2000)
  • K990978 — ALBUMIN BCG, MODEL AL 103-01 (May 25, 1999)
  • K981814 — ALBP (July 22, 1998)
  • K981457 — ALBP (May 27, 1998)
  • K913025 — ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16 (October 9, 1991)
  • K905776 — ALBUMIN REAGENT SET (February 26, 1991)

FDA data resources