Microalbumin Tia Reagent; Malb Calibrator Set 200; Malb Control-L, Control-H

FDA 510(k) K050576 · Good Biotech Corp.

Substantially Equivalent

510(k) numberK050576

Submission

Device name
Microalbumin Tia Reagent; Malb Calibrator Set 200; Malb Control-L, Control-H
Applicant
Good Biotech Corp.
Taichung, TW
Received
March 7, 2005
Decision date
April 21, 2005
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DDZ – Albumin, Fitc, Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5040
Specialty
Immunology

Other 510(k)s with product code DDZ

510(k)DeviceApplicantDecision
K023860Microalbumin Reagent Set and CalibratorsDDZ · Traditional Pointe Scientific, Inc.,04/28/2003SE
K002674Randox MicroalbuminDDZ · Traditional Randox Laboratories, Ltd.10/05/2000SE
K831902Fluorescein Conjugated Immunoglobin-DDZ · Traditional Dako Corp.07/18/1983SE

More from Dako Corp.

510(k)DeviceDecision
K063766Transferrin Tia , Calibrator Set, Control-L,Control-M,Control-H, Model#…DDG · Traditional 04/23/2007SE
K052617Ferritin Lit Assay, Catalog No. 7010; Ferritin Calibrator Set, Catalog No. 7510…DBF · Traditional 02/23/2006SE
K050713Duet Hs-Crp Lit Assay, Catalog Number: 4010, Duet Hs-Crp Calibrator Set, Catalog Number:…DCN · Traditional 06/06/2005SE
K022725Crpex CRP Controls Level L, M, H; Cat. No.: 3011, 3012, 3013JJX · Traditional 09/23/2002SE
K021757Crpex-Br C-Reactive Protein Lit Assay, Crpex-Br CRP Calibrator SetDCN · Traditional 07/29/2002SE
K021882Crpex-Hs CRP Calibrator Set, Catalog No: 1510DCN · Traditional 07/11/2002SE
K020603Crpex-Hs C-Reactive Protein Lit Assay, Catalog No. 1010DCN · Traditional 06/13/2002SE

Questions and answers

When was Microalbumin Tia Reagent; Malb Calibrator Set 200; Malb Control-L, Control-H cleared by the FDA?

Microalbumin Tia Reagent; Malb Calibrator Set 200; Malb Control-L, Control-H (K050576) received a 510(k) decision of Substantially Equivalent on April 21, 2005, 45 days after the submission was received.

What is the product code of K050576?

The FDA product code is DDZ – Albumin, Fitc, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5040.