510(k) K955795

Device: MULTI-CENTRIFUGE
Applicant: NOVONX, INC.
510(k) number: K955795
Product code: GKG
Decision: Substantially Equivalent (SESE)
Decision date: 1996-03-29
Date received: 1995-12-22
Regulation: 864.6400
Classification name: Centrifuge, Hematocrit
Medical specialty: Hematology
Review panel: Hematology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: GLEN S PUTNAM
Address: 2257 S. 11000 E. Suite 1a Salt Lake City UT US 84106 84106

FDA Registration Numbers#

1616487
3006697110
3017065670
3008717264
3005990076
3014150341
3011816315
3012302888
3012942167
3006897996
3003799895
2050012
2249760
3009155756
1067123
3043009938
1061932
2244900

Source Documents#

Other 510(k) Records For Product Code GKG #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K961803	SPUNCRIT (MODEL DRC-40)	Micro Diagnostics Corp.	1996-07-05
K930415	MICROHEMATOCRIT ROTOR	Fisher Scientific Co., LLC	1993-03-23
K925863	SPUNCRIT	bioMerieux, Inc.	1993-02-05
K920207	HERMLE Z230H	Labnet Intl., Inc.	1992-06-09
K920759	CRITSPIN MICRO-HEMATOCRIT	Stat-Spin Technologies	1992-04-29
K913128	HEMATASTAT C-70B	Separation Technology, Inc.	1991-09-23
K890849	HEMATASTAT H-70	Separation Technology, Inc.	1989-03-21
K821803	QBC CENTRIFUGAL HEMATOLOGY SYSTEM	Bd Becton Dickinson Vacutainer Systems Preanalytic	1982-09-14
K822445	HCT CENTRIFUGE	Boehringer Mannheim Corp.	1982-09-14
K813033	CLAY ADAMS QBC CENTRIFUGAL HEMOTOLOGY	Bd Becton Dickinson Vacutainer Systems Preanalytic	1982-04-09

Legacy Summary#

summary

FDA Review#

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