ClearanceBrief
Panels › Hematology › Product code GKR · Class 2

System, Hemoglobin, Automated

Regulation 864.5620

0510(k)s in 12 months (39 all time)
0recalls in 12 months (8 all time)
7recalls that name a 510(k)
Get daily alerts for GKRSample briefCSV

Top companies in GKR

Company510(k)sRecalls
Hemocue AB61
Ekf Diagnostic GmbH40
Siemens Healthcare Diagnostics, Inc.04
Stanbio Laboratory31
Helena Laboratories20
Hematology Marketing Assoc.20
Immunostics Inc.,20
ACON Laboratories, Inc.10
Aktiebolaget Leo Diagnostics10
Avl Scientific Corp.10
Decided510(k)Device and applicantCode
Aug 4, 2020K201217HemoCue Hb 301 System
Hemocue AB, SE
GKR
Jun 12, 2020K200909Hemo Control (optional Add Pack Hemo Control DM)
Ekf-Diagnostic GmbH, DE
GKR
Feb 1, 2019K181751HemoCue Hb 801 System
Hemocue AB, SE
GKR
Nov 16, 2018K182298hemochroma PLUS System
Immunostics Inc.,
GKR
Apr 6, 2018K172173DiaSpect Tm, DiaSpect Tm Cuvettes
Ekf-Diagnostic GmbH, DE
GKR
Sep 8, 2017K163465hemochroma PLUS System
Immunostics Inc.,
GKR
Aug 5, 2013K122553MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM
ACON Laboratories, Inc.
GKR
Jan 7, 2013K121752AVIE TOTAL HB TEST SYSTEM
Mec Dynamics Corp
GKR
Mar 4, 2011K110393EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE W
Ekf-Diagnostic GmbH
GKR
Jun 10, 2009K090093STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM
Stanbio Laboratory
GKR
Jul 18, 2008K081719STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM
Stanbio Laboratory
GKR
Jun 8, 2006K061047HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801
Hemocue AB
GKR
Jun 10, 2004K041234HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM
Hemocue, Inc.
GKR
Oct 24, 2003K032482STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM
Stanbio Laboratory
GKR
Sep 24, 2003K031898EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM
Ekf Diagnostic GmbH
GKR
Aug 25, 2003K032203HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704
Hemocue, Inc.
GKR
Jan 31, 2003K023561ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM
International Technidyne Corp.
GKR
Aug 14, 2002K020710BIOTEST HEMOGLOBIN MEASURING SYSTEM
Biotest Medizintechnik GmbH
GKR
Jul 17, 2002K020616BAYER RAPIDPOINT 405 SYSTEM
Bayer Diagnostics Corp.
GKR
Sep 24, 1996K961312HEMOCUE B-HEMOGLOBIN SYSTEM
Hemocue, Inc.
GKR
Oct 20, 1995K945677IL682, CO-OXIMETER
Instrumentation Laboratory CO
GKR
Oct 5, 1995K954018AVL OMNI ANALYZER
Avl Scientific Corp.
GKR
Jul 11, 1991K910745HEMOGLOBIN REAGENT
Toa Medical Electronics USA, Inc.
GKR
Jun 15, 1988K880353CIBA CORNING MODEL 280 PH/BLOOD GAS SYSTEM
Ciba Corning Diagnostics Corp.
GKR
Apr 28, 1987K870210CLEARVIEW CW-10
Clearview Instruments, Inc.
GKR
Mar 19, 1987K865055DR.BRUNO LANGE MINI-HBA1 PHOTOMETER
Diversa Corp.
GKR
Mar 29, 1985K850096LASER-GLOBIN
Hematology Marketing Assoc.
GKR
Mar 29, 1985K850094LASER-GLOBIN POWDER
Hematology Marketing Assoc.
GKR
Mar 23, 1984K841057HEMOGLOBIN REAGENT SET
Medical Specialties, Inc.
GKR
Oct 28, 1983K832020HEMOCUE PHOTOMETER TECHNICAL MANUAL
Aktiebolaget Leo Diagnostics
GKR
Jun 16, 1983K831618HEMOGLOBIN REAGENT
Omega Medical Diagnostics
GKR
Aug 25, 1981K812127KING DIAGNOSTICS HEMOGLOBIN TEST
King Diagnostics, Inc.
GKR
Dec 30, 1980K803016HELENA HEMESPEC II TOTAL HEMOGLOBIN MET.
Helena Laboratories
GKR
Dec 30, 1980K803015HEMESPEC II
Helena Laboratories
GKR
Oct 23, 1980K802266HGB3 (1:251)
R&D Systems, Inc.
GKR
Feb 8, 1979K790030FLUID, RHEMOX-HB LYSING
Sysmex Corp.
GKR
Sep 14, 1978K781361HEMOGLOBINOMETER MODEL 720 B
Innovative Medical Systems, Inc.
GKR
Jun 22, 1978K780829SYSING AND HEMOGLOBIN REAGENT
Harleco
GKR
Oct 7, 1977K771789BLANKING SOLUTION HGB
J.T. Baker Chemical Co.
GKR

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.