Cleared Traditional

WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791

K053132 · Wako Chemicals USA, Inc. · Chemistry
Dec 2005
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K053132 is an FDA 510(k) clearance for the WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791, a Enzymatic Method, Bilirubin (Class II — Special Controls, product code JFM), submitted by Wako Chemicals USA, Inc. (Richmond, US). The FDA issued a Cleared decision on December 30, 2005, 52 days after receiving the submission on November 8, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.

Submission Details

510(k) Number K053132 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 2005
Decision Date December 30, 2005
Days to Decision 52 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JFM — Enzymatic Method, Bilirubin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1110

Similar Devices — JFM Enzymatic Method, Bilirubin

All 10
ADVIA? Chemistry Total Bilirubin_2 (TBIL_2)
K170065 · Siemens Healthcare Diagnostics, Inc. · Mar 2017
Direct Bilirubin
K152343 · Randox Laboratories Limited · Feb 2016
Total Bilirubin
K152344 · Randox Laboratories Limited · Jan 2016
ADVIA CHEMISTRY TOTAL BILIRUBIN_2
K063845 · Bayer Healthcare, LLC · Dec 2007
WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191
K053131 · Wako Chemicals USA, Inc. · Dec 2005
DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR
K053090 · Beckman Coulter, Inc. · Dec 2005

More from Wako Chemicals USA, Inc.

View all
UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION
K100464 · NSF · Feb 2011
APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201
K080125 · LBS · Jul 2008
APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201
K080123 · CFR · Jul 2008
WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR
K061775 · JFY · Feb 2007
WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401
K062368 · OAU · Jan 2007