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510(k) K873553

Device
WAKO(TM) PRETEST 8A
Applicant
WAKO CHEMICALS, USA, INC.
510(k) number
K873553
Product code
JJB  
Decision
Substantially Equivalent (SESE)
Decision date
1987-09-22
Date received
1987-08-28
Regulation
862.1115
Classification name
Azo-dyes, Colorimetric, Bilirubin & Its Conjugates (urinary, Non-quant.)
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
TOSHIHIKO ODA
Address
12300 Ford Rd. Suite 130 Dallas TX US 75234 75234

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JJB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K943436URINE REAGENT STRIPS-8 PARAMETERSTeco Diagnostics1995-04-24
K943008BIOSCAN REAGENT STRIPSGenesis Labs, Inc.1994-08-08
K862806URINE DIAGNOSTIC REAGENT STRIPSAmatech International, Inc.1986-12-04
K833521REAGENT TESTS STRIP COMBINATIONSSyn-Kit, Inc.1984-01-11

Legacy Summary#

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FDA Review#

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