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510(k) K040226

Device
WAKO AUTO KIT PREALBUMIN, WAKO AUTOKIT PREALBUMIN CALIBRATOR SET, PREALBUMIN CONTROL SET
Applicant
Wako Chemicals USA, Inc.
510(k) number
K040226
Product code
JIT
Decision
Substantially Equivalent (SESE)
Decision date
2004-03-25
Date received
2004-02-02
Regulation
862.1150
Classification name
Calibrator, Secondary
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
LORI CREASY
Address
1600 Bellwood Rd. Richmond VA US 23237 23237

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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K152526Elecsys Progesterone III CalSetRoche Diagnostics2015-10-02
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K142985UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL CalibratorBeckman Coulter, Inc.2015-02-26