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Panels › Hematology › Product code JPI · Class 2

Device, Hematocrit Measuring

Regulation 864.6400

0510(k)s in 12 months (15 all time)
0recalls in 12 months (9 all time)
9recalls that name a 510(k)
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Top companies in JPI

Company510(k)sRecalls
Abbott Point of Care, Inc.18
Fisher Scientific Co., LLC20
Norfolk Scientific, Inc.20
Abbott Laboratories10
Baxter Healthcare Renal Div01
Biodynamics Corp.10
Em Diagnostic Systems, Inc.10
Hans J. Brouwers & Assoc.10
Heraeus-Christ GmbH10
In-Line Diagnostics Corp.10
Decided510(k)Device and applicantCode
Feb 28, 2020K183680i-STAT CHEM8+ cartridge with the i-STAT 1 System
Abbott Point of Care, Inc.
JPI
Aug 22, 2017K163342i-STAT Hematocrit test with i-STAT Alinity System
Abbott Laboratories
JPI
Mar 14, 1995K950942CRIT-LINE HEMATOCRIT ALERT
In-Line Diagnostics Corp.
JPI
May 7, 1993K924167CRIT-LINE
Noninvasive Medical Technology Corp.
JPI
Sep 17, 1990K903698STATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBES
Statspin Technologies
JPI
Jun 20, 1990K902028STATSPIN ILLUMINATED MICRO-HEMATOCRIT TUBE READER
Norfolk Scientific, Inc.
JPI
Mar 16, 1987K870511CHART-TYPE MICRO HEMATOCRIT TUBE READER
Norfolk Scientific, Inc.
JPI
Jul 15, 1985K852516CENTIFUGE, HEMATOCRIT & MICROSEDIMENTATION COMBINE
Whittaker General Medical
JPI
Jul 15, 1985K852482MICROSPIN MINICENTRIFUGE ITEM NO. 65204/94
Em Diagnostic Systems, Inc.
JPI
May 10, 1985K850391PLASMA EXTRACTION SYSTEM
Hans J. Brouwers & Assoc.
JPI
Apr 17, 1984K840767HAEMOFUGE A. BIOFUGE A. & B
Heraeus-Christ GmbH
JPI
Jun 8, 1983K831318COMPUR* M1100 HEMATRCRIT SYSTEM
Worthington Diagnostic Systems
JPI
Mar 24, 1983K830578MICROHEMATOCRIT READER
Fisher Scientific Co., LLC
JPI
Jan 21, 1983K823558MICRO-HEMATOCRIT CENTRIFUGE 335/336
Fisher Scientific Co., LLC
JPI
Sep 30, 1982K822716UNIVERSAL CENTRIFUGE
Biodynamics Corp.
JPI

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