510(k) K050576

Device: MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H
Applicant: GOOD BIOTECH CORP.
510(k) number: K050576
Product code: DDZ
Decision: Substantially Equivalent (SESE)
Decision date: 2005-04-21
Date received: 2005-03-07
Regulation: 866.5040
Classification name: Albumin, Fitc, Antigen, Antiserum, Control
Medical specialty: Immunology
Review panel: Clinical Chemistry
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K023860	MICROALBUMIN REAGENT SET AND CALIBRATORS	Pointe Scientific, Inc.,	2003-04-28
K002674	RANDOX MICROALBUMIN	Randox Laboratories, Ltd.	2000-10-05
K831902	FLUORESCEIN CONJUGATED IMMUNOGLOBIN-	Dako Corp.	1983-07-18

summary

Decision Summary