510(k) K820768

Device: COLORIMETRIC LDH REAGENT SET
Applicant: BIORENT DIAGNOSTIC, INC.
510(k) number: K820768
Product code: CFH
Decision: Substantially Equivalent (SESE)
Decision date: 1982-04-14
Date received: 1982-03-22
Regulation: 862.1440
Classification name: Tetrazolium Int Dye-diaphorase, Lactate Dehydrogenase
Medical specialty: Clinical Chemistry
Review panel: Clinical Chemistry
Device class: 2
Clearance type: Traditional
Third party reviewed: No

Applicant Contact#

Address: 803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

3021841051
1832216

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CFH #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K050790	SPOTCHEM II LDH TEST	Arkray, Inc.	2005-06-06
K020484	CARESIDE LDH	Careside, Inc.	2002-07-03
K895138	CLINISTAT LDH REAGENT TEST	Heraeus Kulzer, Inc.	1989-10-19
K894578	IQ LDH	Bd Becton Dickinson Vacutainer Systems Preanalytic	1989-10-17
K880630	LACTATE DEHYDROGENASE (LDH-L)	Tech-Co, Inc.	1988-03-16
K860349	LACTATE DEHYDROGENASE (LDH) REAGENT SET	Sterling Diagnostics, Inc.	1986-02-28
K852391	EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE	Helena Laboratories	1985-10-01
K842452	WAKO LDH CII TEST	Wako Chemicals USA, Inc.	1984-08-15
K812836	LDH REAGENT SET	Anco Medical Reagents & Assoc.	1981-10-09
K782176	HYCEL LDH-INT TEST	Hycel, Inc.	1979-01-26
K771343	LDH-INT TEST	Hycel, Inc.	1977-08-10
K760009	COLORIMETRIC DETERMINATION (LDH)	The Dow Chemical Co.	1976-07-20

Legacy Summary#

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