FDA.reportPublic FDA data

510(k) K853532

Device
ALCOHOL CALIBRATORS
Applicant
DIAGNOSTIC SYSTEMS
510(k) number
K853532
Product code
DNN  
Decision
Substantially Equivalent (SESE)
Decision date
1985-09-16
Date received
1985-08-23
Regulation
862.3200
Classification name
Calibrators, Ethyl Alcohol
Medical specialty
Toxicology
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
RAYMOND L MILLER
Address
480 Democrat Rd. Gibbstown NJ US 08027 08027

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
K882117ETHYL ALCOHOL STANDARDVerichem Laboratories, Inc.1988-08-04
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