510(k) K831140

Device: DADE HEMATOLOGY CALIBRATOR
Applicant: AMERICAN DADE
510(k) number: K831140
Product code: KRX
Decision: Substantially Equivalent (SESE)
Decision date: 1983-06-08
Date received: 1983-04-07
Regulation: 864.8150
Classification name: Calibrator For Cell Indices
Medical specialty: Hematology
Review panel: Hematology
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#

1061932
3007603826
1950302
3008311438
9613959
1064608
3014150341
2221819
3000148879
2182501
3009711478
3016438761
3005333358
3003741796
2432235

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KRX #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K160585	XN CAL	Streck	2016-12-22
K141955	XN CAL PF	Streck	2014-12-05
K141962	XN CAL	Streck	2014-12-05
K120747	XN CAL PF	Streck	2012-10-22
K120745	XN CAL	Streck	2012-10-19
K111204	CELL-DYN 22 PLUS CALIBRATOR	Streck	2011-12-22
K083200	X-CAL	Streck	2009-02-03
K020469	CAL-CHEX CD PLUS	Streck Laboratories, Inc.	2002-04-04
K003991	CD-CAL PLUS CALIBRATOR	R&D Systems, Inc.	2001-01-16
K993375	CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER	Clinical Diagnostic Solutions, Inc.	1999-12-20
K955925	CBC-CAL PLUS HEMATOLOGY CALIBRATOR	R&D Systems, Inc.	1996-02-29
K912357	3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE	R&D Systems, Inc.	1991-07-09
K862858	CBC-CAL (TM) PLUS/MULTIPLE	R&D Systems, Inc.	1986-08-21
K811741	CELL-CHEX RBC	Streck Laboratories, Inc.	1981-09-24
K811063	LASER-CAL	Diagnostic Technology, Inc.	1981-07-01

Legacy Summary#

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