Cleared Traditional

WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD

K993928 · Wako Chemicals USA, Inc. · Immunology
Jan 2000
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K993928 is an FDA 510(k) clearance for the WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD, a Igg, Antigen, Antiserum, Control (Class II — Special Controls, product code DEW), submitted by Wako Chemicals USA, Inc. (Richmond, US). The FDA issued a Cleared decision on January 18, 2000, 61 days after receiving the submission on November 18, 1999. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K993928 FDA.gov
FDA Decision Cleared SESE
Date Received November 18, 1999
Decision Date January 18, 2000
Days to Decision 61 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DEW — Igg, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510

Similar Devices — DEW Igg, Antigen, Antiserum, Control

All 75
TINA-QUANT IGG GEN.2
K050113 · Roche Diagnostics Corp. · Feb 2005
ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2
K040434 · Roche Diagnostics Corp. · Mar 2004
SPIFE IFE CALIBRATOR AND CONTROL KIT
K010617 · Helena Laboratories · Mar 2001
K-ASSAY IGG
K993281 · Kamiya Biomedical Co. · Nov 1999
IGG
K983221 · Abbott Laboratories · Nov 1998
IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN
K963974 · Beckman Instruments, Inc. · Mar 1997

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