FDA.reportPublic FDA data

510(k) K941807

Device
INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENT
Applicant
INTERSECT SYSTEMS, INC.
510(k) number
K941807
Product code
CHG  
Decision
Substantially Equivalent (SESE)
Decision date
1994-09-14
Date received
1994-04-12
Regulation
862.1170
Classification name
Acid, Phosphoric-tungstic (spectrophotometric), Chloride
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
TARAS TATARKO
Address
1152 3rd Ave., Suite D/E P.O. Box 2219 Longview WA US 98632 98632

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CHG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K934588CHLORIDE (MF) ASSAYDiagnostic Chemicals , Ltd.1994-02-18
K903103SYNERMED CHLORIDE REAGENT KITSynermed, Inc.1990-08-09

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases