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Review Panel

Hematology FDA 510(k) Clearances & Devices

Cleared Devices
4,197
Product Codes (page)
48
Latest Decision
1978-11-15

Clearances · page 41 of 42

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K781745 QUANTICEL HHR, L531 AND L532 Bhp Diagnostix, Inc. JPK Class II 1978-11-15
K781891 PIPETTES, PLASTIC DISPOSABLE Hillwood Corp. GJG Class I 1978-11-15
K781811 TRANSFER PAK 4R 9006 Travenol Laboratories, S.A. KSR Class II 1978-11-08
K781480 ANTITHROMBIN III ASSAY Dade, Baxter Travenol Diagnostics, Inc. JBQ Class II 1978-11-08
K781814 SULFATE, FIBRIQUIK PROTAMINE General Diagnostics JBN Class II 1978-11-08
K781851 HEMOGLOBIN, TESTING SYSTEM Isolab, Inc. LCP Class II 1978-11-07
K780819 GLYCOHEMOGLOBIN-SKREEN TEST KIT Eppendorf-Brinkmann, Inc. LCP Class II 1978-11-07
K780573 TECHNIQUE, CHROMATOGRAPHIC, HEMOGLOBIN Bd Becton Dickinson Vacutainer Systems Preanalytic LCP Class II 1978-11-07
K781628 HEMO-W SYSTEM Coulter Electronics, Inc. GKL Class II 1978-10-27
K781710 BUFFER, COLLAGEN REAGENT AND DILUENT Diagnostica, Inc. JBX Class II 1978-10-24
K781572 NORMAL HEMATOLOGY CONTROL UNASSAYED Ortho Diagnostics, Inc. JPK Class II 1978-10-17
K781573 ABNORMAL HEMATOLOGY CONTROL UNASSAYED Ortho Diagnostics, Inc. JPK Class II 1978-10-17
K781587 HEMATOLOGY STAIN PACK Bioscientific IAF Class I 1978-10-10
K781584 GRAM STAIN KIT Bioscientific HYI Class I 1978-10-10
K781601 TEKNI-CAL Streck Laboratories, Inc. KRY Class II 1978-10-10
K781582 PAPANICOLAOU STAIN EA-36 Bioscientific HZJ Class I 1978-10-10
K781585 HEMATOXYLIN STAIN HARRIS Bioscientific HYK Class I 1978-10-10
K781583 PAPANICOLAOU STAIN :EA-50: Bioscientific HZJ Class I 1978-10-10
K781588 PAPANICOLAOU STIAN OG-6 Bioscientific HZJ Class I 1978-10-10
K781643 ACID FAST KIT Bioscientific JTS Class I 1978-10-03
K781103 SPECTRASCAN Medishield, Inc. DAT Class II 1978-09-27
K781516 TEST SYSTEM TISSUE CELL CULTURE SLIDE Zeus Scientific, Inc. KIY Class I 1978-09-27
K781397 EM-V Biological Corp. of America KSG Class II 1978-09-14
K781146 HEMAC LASER HEMATOLOGY SYSTEM Ortho Instruments GKL Class II 1978-09-14
K781247 QUANTICEL-HRP Bhp Diagnostix, Inc. JPK Class II 1978-09-14
K781361 HEMOGLOBINOMETER MODEL 720 B Innovative Medical Systems, Inc. GKR Class II 1978-09-14
K781435 ORTHO LOW IONIC SOLUTION Ortho Diagnostics, Inc. KSG Class II 1978-09-14
K781390 MYCOPLASMA HYORHINIS (BTS-7) Flow Laboratories, Inc. KPB Class I 1978-09-01
K781122 LIPOPROTEIN STAIN Electrophoresis Corp. of America HZG Class I 1978-08-31
K781347 CAMCO QUIK STAIN II Cambridge Chemical Products, Inc. IAF Class I 1978-08-21
K781384 WRIGHT RAPID STAIN Mfg Chemists, Inc. IAF Class I 1978-08-21
K781391 PBS FOR FA (46-991-49) Flow Laboratories, Inc. KIP Class I 1978-08-21
K781119 ECA HEME BUFFER Electrophoresis Corp. of America JBD Class II 1978-08-14
K781059 CUTTER/COMPUR MINI CENTRIFUGE Cutter Laboratories, Inc. GKF Class II 1978-08-14
K781133 PC-CALIBRATOR Streck Laboratories, Inc. KRY Class II 1978-08-14
K781061 DROPPERS, SOLUTION, IODINE Marion Laboratories, Inc. JTS Class I 1978-08-14
K781062 DROPPER, SOLUTION TRICHROME, CEPTI-SEAL Marion Laboratories, Inc. HYW Class I 1978-08-14
K780869 CELL CULTURE LINES Bioassay Systems Research Corp. KIR Class I 1978-08-14
K781121 HEMOLYSE Electrophoresis Corp. of America GGK Class I 1978-08-14
K781104 PLASMA COAGULATION CONT., ABNORMAL Ortho Diagnostics, Inc. GFO Class II 1978-08-10
K781026 ANTITHROMBIN III SERUM, ANTI-HUMAN Icl Scientific JBQ Class II 1978-08-10
K780980 PLATELET CONTROL Bhp Diagnostix, Inc. JPK Class II 1978-07-27
K781077 CONTROL, HEMATOLOGY, CH-60 Dade, Baxter Travenol Diagnostics, Inc. JPK Class II 1978-07-27
K780962 AUTOMATED ENZYME Hyland Therapeutic Div., Travenol Laboratories KSK Class II 1978-07-27
K780946 ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER Hycel, Inc. JPJ Class II 1978-07-27
K780564 FECATEST Otto C. Watzka KHE Class II 1978-06-30
K780911 SYSMEX PLATELET COUNTER, PL-110 Toa Medical Electronics USA, Inc. GKL Class II 1978-06-28
K780910 SYSTEM AUTO. BLOOD CELL COUNTER CC-110 Toa Medical Electronics USA, Inc. GKL Class II 1978-06-28
K781008 ISOTONIC DILUENT Mallinckrodt Critical Care GIF Class I 1978-06-28
K780909 SYSMEX AUTO. BLOOD CELL COUNTER, CC-120 Toa Medical Electronics USA, Inc. GKL Class II 1978-06-28
K780835 ARANTROL Aranco Diagnostic Laboratories, Inc. JPK Class II 1978-06-22
K780829 SYSING AND HEMOGLOBIN REAGENT Harleco GKR Class II 1978-06-22
K780830 ISOTONIC BUFFERED SALINE Harleco GIF Class I 1978-06-14
K780354 CRYOCYTE PACK Travenol Laboratories, S.A. KSR Class II 1978-06-14
K780810 MLA ELECTRA 750 COAGULATION TIMER Medical Laboratory Automation Systems, Inc. JPA Class II 1978-06-14
K780665 RECAP Bca Biological Corp. of America KSF Class II 1978-06-06
K780714 PLATELET CONTROL Bhp Diagnostix, Inc. JPK Class II 1978-06-06
K780807 HBF-QUIPLATE METHODOLOGY Helena Laboratories JBD Class II 1978-06-02
K780577 PLATELETS/CU MM Geometric Data, Div. Smithkline Corp. GKZ Class II 1978-05-19
K780224 MICROCELL COUNTER MODEL CC-108 Toa Medical Electronics USA, Inc. GKL Class II 1978-05-19
K780214 HEMO FEC Boehringer Mannheim Corp. KHE Class II 1978-05-03
K780556 SPECT RIM (LISS) Bd Becton Dickinson Vacutainer Systems Preanalytic KSG Class II 1978-04-24
K780097 QUALITY CONTROL SYSTEM, SPECTRA Bd Becton Dickinson Vacutainer Systems Preanalytic KSF Class II 1978-04-24
K780413 LOW IIONIC STRENGTH SOLUTION Pfizer, Inc. KSG Class II 1978-04-24
K780355 ATROXIN Sigma Chemical Co. JCO Class II 1978-04-18
K780285 SOLUBLE COLLAGEN General Diagnostics JOZ Class II 1978-03-30
K780189 PLATELET ROTATOR Travenol Laboratories, S.A. KSQ Class I 1978-03-30
K780163 REDI-DISC HEMOGLOBIN GEL TUBE KIT Miles Laboratories, Inc. JBD Class II 1978-03-27
K780203 THROMBOPLASTIN DRIED Hyland Therapeutic Div., Travenol Laboratories GJS Class II 1978-03-27
K780305 CELL Dynatech Laboratories, Inc. KJF Class I 1978-03-27
K780140 CELL-CHEX Streck Laboratories, Inc. JPK Class II 1978-03-27
K780346 MIF PROCEDURE KIT Marion Laboratories, Inc. JTS Class I 1978-03-22
K780237 DISPOSABLE CONTROLLED DROP PASTEUR PIPET Owens-Illinois, Inc. GJG Class I 1978-03-09
K780281 IMMUFUGE DISP. LINER Dade, Baxter Travenol Diagnostics, Inc. KSO Class I 1978-03-02
K780047 PLATELET AGGREGATING REAGENTS Dade, Baxter Travenol Diagnostics, Inc. JOZ Class II 1978-03-02
K772195 HEMATOLOGY REFERENCE CONTROLS R&D Systems, Inc. JPK Class II 1978-02-03
K772328 LAS-R HUMAN ANTITHROMBIN III TEST Hyland Therapeutic Div., Travenol Laboratories JBQ Class II 1978-02-03
K780002 ANTITHROMBIN III ASSAY Ortho Diagnostics, Inc. JBQ Class II 1978-01-31
K770143 TQC CALIBRATION REFERENCE FOR PLATELETS Technicon Instruments Corp. KRY Class II 1978-01-30
K780012 ANTITHROMBIN III RIA Ria Diagnostics DDQ Class II 1978-01-20
K780009 GUINEA PIG WHOLE SERUM Northeast Biomedical Labs., Inc. KIS Class I 1978-01-20
K772139 RE-CELL SLIDE RECAP Geometric Data, Div. Smithkline Corp. JOY Class II 1978-01-05
K772140 SCANNING SYS., AUTO. COMP., ACS1000 Honeywell, Inc. JOY Class II 1977-12-05
K772105 PLATELET KIT Streck Laboratories, Inc. GLG Class I 1977-11-30
K771753 HEMATOLOGY REFERENCE CONTROL Coulter Electronics, Inc. JPK Class II 1977-11-28
K771678 THROMBO-SCREEN PLATELET ADHESION Bay Area Hema. Onco. Clinic. & Res. L JBZ Class II 1977-11-22
K771523 LATELET RETENTION COLUMN Bd Becton Dickinson Vacutainer Systems Preanalytic JBZ Class II 1977-11-22
K771867 MYCOPLASMA DETECTION KIT Bioassay Systems Research Corp. KPB Class I 1977-11-17
K771512 COUNTER MODEL S PLUS BLOOD CELL COUNTER Coulter Electronics, Inc. GKL Class II 1977-11-09
K771669 DIAG. KIT FOR TOTAL ANTITHROMBIN III Abbott Laboratories JBQ Class II 1977-11-09
K771487 LEWIS BLOOD GROUP SUBSTANCE Ortho Diagnostics, Inc. KSX Class II 1977-11-08
K771488 P1 BLOOD GROUP SUBSTANCE Ortho Diagnostics, Inc. KSX Class II 1977-11-08
K771814 REAGENT CONFIDENCE SERA Ortho Diagnostics, Inc. KSF Class II 1977-11-07
K771728 AUTO. LEUCOCYTE DIFFER. ANALYZER D/90 Technicon Instruments Corp. GKL Class II 1977-11-07
K771777 PONCEAU S CONCENTRATE Sigma Chemical Co. HZO Class I 1977-10-25
K771898 AUTOMATED SLIDE SPINNER Dynatech Cryomedical Co. GKJ Class I 1977-10-18
K761207 HEMATRAK RBC MORPHOLOGY Geometric Data, Div. Smithkline Corp. GKZ Class II 1977-10-18
K771649 HEMOGLOBIN A2 TESTING SYSTEM Isolab, Inc. JBD Class II 1977-10-07
K771787 AZIDE FREE BLOOD DILUTING REAGENT J.T. Baker Chemical Co. GIF Class I 1977-10-07
K771788 CYMET-AUTOMATED J.T. Baker Chemical Co. GGK Class I 1977-10-07

4,197 clearances in the Hematology panel. Data: openFDA.