FDA.reportPublic FDA data

510(k) K844965

Device
LEUCINE AMINOPEPTIDASE REAGENT
Applicant
ALLADIN DIAGNOSTIC, INC.
510(k) number
K844965
Product code
JGG  
Decision
Substantially Equivalent (SESE)
Decision date
1985-03-05
Date received
1984-12-24
Regulation
862.1460
Classification name
L-leucine-4-nitroanilide (colorimetric), Leucine Arylamidase
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ELIOT WOODBRIDGE
Address
84 Bayard Ln. Princeton NJ US 08540 08540

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JGG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K895850SYNCHRON CX SYSTEMS (LAP) REAGENT KITBeckman Instruments, Inc.1989-12-05

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