FDA.reportPublic FDA data

510(k) K882117

Device
ETHYL ALCOHOL STANDARD
Applicant
VERICHEM LABORATORIES, INC.
510(k) number
K882117
Product code
DNN  
Decision
Substantially Equivalent (SESE)
Decision date
1988-08-04
Date received
1988-05-19
Regulation
862.3200
Classification name
Calibrators, Ethyl Alcohol
Medical specialty
Toxicology
Review panel
Toxicology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ANTHONY J DIMONTE
Address
90 Narragansett Ave. Providence RI US 02907 02907

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DNN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K990516ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONSEmd Chemicals, Inc.1999-03-31
K973054ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONSEmd Chemicals, Inc.1997-10-01
K924733ETHYL ALCOHOL CALIBRATORS & CONTROLDiagnostic Reagents, Inc.1992-12-09
K853532ALCOHOL CALIBRATORSDiagnostic Systems1985-09-16
K810466ETHYL ALCOHOL SERUM CALIBRATORSyva Co.1981-03-06
K802620EMIT-STM ETHYL ALCOHOL URINE CALIBRATORSyva Co.1980-10-31

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