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Review Panel

Hematology FDA 510(k) Clearances & Devices

Cleared Devices
4,197
Product Codes (page)
34
Latest Decision
1984-07-27

Clearances · page 33 of 42

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K842636 TECHNICON H*1 SYSTEM Technicon Instruments Corp. GKZ Class II 1984-07-27
K842346 COULTER AUTOMATIC SAMPLE HANDLER Coulter Electronics, Inc. GKL Class II 1984-07-27
K841531 PARA-TEK Streck Laboratories, Inc. JPK Class II 1984-07-27
K842440 SICKLE CELL STAT A/S HETEROZYGOUS-ERYTH Anco Medical Reagents & Assoc. JPK Class II 1984-07-27
K842146 HISTOPAQUE-1077 Sigma Chemical Co. JCF Class I 1984-07-27
K842584 HEK Viromed Laboratories, Inc. KIR Class I 1984-07-27
K842109 TECHNICON TEST POINT ASSAYED HEMATOLOGY Technicon Instruments Corp. JPK Class II 1984-07-27
K842583 SIRC Viromed Laboratories, Inc. KIR Class I 1984-07-27
K842671 BASAL MED. EAGLE B8265, W/EARLS SALTS Sigma Chemical Co. KIT Class I 1984-07-20
K842368 SICKLE CELL REAGENT SET Livonia Diagnostics, Inc. GHM Class II 1984-07-20
K842672 MINIMUM ESSENTIAL MED. M0769 W/WO Sigma Chemical Co. KIT Class I 1984-07-20
K841708 MELOY IMMUNOSTAT MONOCLONAL FACTOR VIII Meloy Laboratories, Inc. GGP Class II 1984-07-19
K840649 DANAM ELEC. SA-1000 Danam Electronics GKL Class II 1984-07-19
K841957 BOVINE FACTOR XA-HUMAN FACTOR XA Haemachem, Inc. GGP Class II 1984-07-19
K841956 BOVINE THROMBIN, HUMAN THROMBIN Haemachem, Inc. GJA Class II 1984-07-19
K841465 GENERAL DIAGNOSTICS PLATELET ANTIBODY General Diagnostics LLG Class II 1984-07-02
K842069 IDL-LYSING REAGENT Interscience Diagnostics, Inc. GGK Class I 1984-07-02
K842068 IDI ISOTONIC DILUENT Interscience Diagnostics, Inc. GIF Class I 1984-07-02
K841998 IMR-90-DIPLOID-HUMAN FETAL LUNG CELL Bartels Immunodiagnostic Supplies, Inc. KIR Class I 1984-06-27
K842017 PARA 4 Streck Laboratories, Inc. JPK Class II 1984-06-26
K841993 HL-1, DEFINED SERUM FREE MEDIA Ventrex Laboratories, Inc. KIT Class I 1984-06-25
K842002 HANKS BALANCED SALTS-HBSS H2387 Sigma Chemical Co. KIT Class I 1984-06-22
K841999 BGM CELL CULTURE AFRICAN GREEN MONKEY Bartels Immunodiagnostic Supplies, Inc. KIR Class I 1984-06-22
K842000 PRIMARY RABBITT KIDNEY CELL CULTURE Bartels Immunodiagnostic Supplies, Inc. KIR Class I 1984-06-22
K834024 HEPARINOMETER Western Laboratories Corp. KFF Class II 1984-06-11
K841504 QUICK-COUNT PLUS 2 Seragen Diagnostics, Inc. GKL Class II 1984-06-11
K841806 WI-38 Viromed Laboratories, Inc. KIR Class I 1984-06-07
K840744 TRANSPORTER VIRAL TRANSPORT MEDIUM Bartels Immunodiagnostic Supplies, Inc. KIT Class I 1984-06-07
K841366 DIA FIBRIN Diatech, Inc. KQJ Class II 1984-06-01
K841462 HEPARIN COAGULATION CONTROL PLASMA 1- Diatech, Inc. JPA Class II 1984-06-01
K841523 OWREN'S VERONAL BUFFERR Diatech, Inc. JPA Class II 1984-06-01
K841365 DIA REPTIN Diatech, Inc. GIR Class I 1984-06-01
K841800 LYSING & HEMOGLOBIN REAGENT Reagent Laboratory, Inc. GGK Class I 1984-05-31
K841848 RETIC-SET R&D Systems, Inc. KQC Class I 1984-05-31
K841799 CYANOMETHEMOGLOBIN REAGENT Reagent Laboratory, Inc. GIF Class I 1984-05-31
K841021 HEMOTEC, HEPCON/SYS B-10 HEPARIN/PROTAM Hemotec, Inc. JOX Class II 1984-05-25
K841744 DULBECCO'S PHOSPHATE BUFFERED SALINE Sigma Chemical Co. KIT Class I 1984-05-11
K841342 ULTRACLONE ECL-01-400 CELL LINE Earl-Clay Laboratories, Inc. KIR Class I 1984-05-11
K841338 ULTRACLONE ECL-01-600 CELL LINE Earl-Clay Laboratories, Inc. KIR Class I 1984-05-11
K841339 ULTRA CLONE ECL-01-700 CELL LINE Earl-Clay Laboratories, Inc. KIR Class I 1984-05-11
K841340 ULTRACLONE ECL-01-900 CELL LINE Earl-Clay Laboratories, Inc. KIR Class I 1984-05-11
K841346 ULTRACLONE ECL-01-200 CELL LINE Earl-Clay Laboratories, Inc. KIR Class I 1984-05-11
K841345 ULTRACLONE ECL-01-500 CELL LINE Earl-Clay Laboratories, Inc. KIR Class I 1984-05-11
K841337 ULTRACLONE ECL-01-800 CELL LINE Earl-Clay Laboratories, Inc. KIR Class I 1984-05-11
K841343 ULTRACLONE ECL-01-100 CELL LINE Earl-Clay Laboratories, Inc. KIR Class I 1984-05-11
K841344 ULTRACLONE ECL-01-300 CELL LINE Earl-Clay Laboratories, Inc. KIR Class I 1984-05-11
K841341 ULTRACLONE ECL-01-1000 CELL LINE Earl-Clay Laboratories, Inc. KIR Class I 1984-05-11
K841665 RHESUS SV5/SV40 Viromed Laboratories, Inc. KIR Class I 1984-05-07
K841666 RABBIT KIDNEY CELLS Viromed Laboratories, Inc. KIR Class I 1984-05-07
K834595 PARAGON ACID HEMOGLOBIN REAGENT KIT Beckman Instruments, Inc. GKA Class II 1984-05-07
K841461 COAGULATION CONTROL PLASMA LEVEL 1/2/3 Diatech, Inc. GGP Class II 1984-05-02
K841020 FIBRINOGEN ASSAY KIT Helena Laboratories KQJ Class II 1984-05-02
K841239 ASSIGNED VALUE FOR MEAN PLATELET Coulter Electronics, Inc. JPK Class II 1984-05-02
K840802 DIA THROMBIN DIA PLASTIN Diatech, Inc. GJS Class II 1984-05-01
K840195 FACS ANALYZER Bd Becton Dickinson Vacutainer Systems Preanalytic GKZ Class II 1984-04-30
K840928 FACTOR DEFICIENT SUBSTRATE PLASMA VIII Diatech, Inc. GGP Class II 1984-04-30
K840927 FACTOR DEFICIENT SUBSTRATE PLASMA II Diatech, Inc. GGP Class II 1984-04-30
K841522 CALCIUM CHLORIDE Diatech, Inc. GGW Class II 1984-04-30
K841364 COAGULATION FACTOR V DEFICIENT SUBSTR American Dade GGP Class II 1984-04-25
K840210 REPTILASE-R HA35 Wellcome Diagnostics JCO Class II 1984-04-23
K840288 DIACELIN Diatech, Inc. GGN Class II 1984-04-23
K834116 DEAE-DEXTRAN IN PBS Bartels Immunodiagnostic Supplies, Inc. KIT Class I 1984-04-20
K840257 RAPID IMMUNO-ASSAY SYS Applied Polytechnology, Inc. LLG Class II 1984-04-19
K840010 DADE HEMATOLOGY CALIBRATOR PLUS American Dade KRZ Class II 1984-04-19
K840767 HAEMOFUGE A. BIOFUGE A. & B Heraeus-Christ GmbH JPI Class II 1984-04-17
K840658 QBC CENTRIFUGAL HEMATOLOGY ANALYZ Bd Becton Dickinson Vacutainer Systems Preanalytic GKL Class II 1984-04-17
K841272 SICKLE-STAT HEMOGLOBIN S SCREEN KIT Clinical Technology Corp. GHM Class II 1984-04-13
K840329 RISTOCETIN COFACTOR ASSAY Helena Laboratories GGP Class II 1984-04-05
K841170 SICKLE HB ASSAY Isolab, Inc. GHM Class II 1984-04-04
K841026 MANUAL BLOOD CELL COUNTING DEVICE Instrumentation Laboratory CO GKM Class I 1984-04-04
K840794 S-CAL HEMATOLOGY CALIBRATOR Coulter Electronics, Inc. KRY Class II 1984-04-04
K834113 TISSUE CULTURE REFEEDING MEDIUM Bartels Immunodiagnostic Supplies, Inc. KIT Class I 1984-03-23
K841057 HEMOGLOBIN REAGENT SET Medical Specialties, Inc. GKR Class II 1984-03-23
K833957 ERYTHROPOIETIN EIA Jcl Clinical Research Corp. GGT Class II 1984-03-23
K834120 LLC-MK2-RHESUS MONKEY KIDNEY CELLS Bartels Immunodiagnostic Supplies, Inc. KIR Class I 1984-03-22
K834126 MRC-5 CELLS Bartels Immunodiagnostic Supplies, Inc. KIR Class I 1984-03-22
K834124 VERO CELLS Bartels Immunodiagnostic Supplies, Inc. KIR Class I 1984-03-22
K834136 PBS W/MG+2 & CA+2 Bartels Immunodiagnostic Supplies, Inc. KIT Class I 1984-03-22
K834119 MCCOY CELLS Bartels Immunodiagnostic Supplies, Inc. KIR Class I 1984-03-22
K834117 HUMAN FIBROBLASTIC CELLS-HUMAN NEWBORN Bartels Immunodiagnostic Supplies, Inc. KIR Class I 1984-03-22
K834123 WI-38 HUMAN LUNG CELLS Bartels Immunodiagnostic Supplies, Inc. KIR Class I 1984-03-22
K840302 PLT - 4 PLATELET R&D Systems, Inc. JPK Class II 1984-03-12
K840798 AMYLOID STAIN, CONGO RED HT 60 Sigma Chemical Co. ICH Class I 1984-03-12
K834371 TRI-COUNT 10 Hematology Marketing Assoc. JPK Class II 1984-03-09
K840289 LYSE-TEC Medilab Corp. GGK Class I 1984-03-05
K840041 SDI PREPAX DILUKIT HW Scientific Distributors, Inc. GIF Class I 1984-03-05
K840477 UNITIZED HEMATOLOGY SET 65132/93 Emd Chemicals, Inc. GIF Class I 1984-03-05
K840170 CELL-DYN 100 WHOLE BLOOD PLATELET Abbott Diagnostics GKL Class II 1984-03-02
K840211 FIBRI-PREST AUTOMATE HA34 Wellcome Diagnostics KQJ Class II 1984-03-02
K832311 HEMOCCULT-C Menley & James Laboratories KHE Class II 1984-02-27
K840500 SEDIPLAST Precision Technology, Inc. JPH Class I 1984-02-21
K840261 CAL-CHEX, A HEMATOLOGY CALIBRATOR Streck Laboratories, Inc. KRZ Class II 1984-02-21
K840054 PAPANICOLAOU STAIN SYS HT40 Sigma Chemical Co. HZJ Class I 1984-02-17
K833972 QUICK-COUNT HEMATOLOGY REAGENT KIT Seragen Diagnostics, Inc. GIF Class I 1984-02-17
K834122 CHLAMYDIAE ISOLATION MEDIUM W/CYCLOHEX Bartels Immunodiagnostic Supplies, Inc. KIT Class I 1984-02-13
K840043 SDI PREPAX DILUKIT CT Scientific Distributors, Inc. GIF Class I 1984-02-10
K840087 PRESERV GOMORI TRICHROME STAIN 125/500 Preventive Diagnostics Corp. LED Class I 1984-02-10
K834568 COULTER COUNTER M2 Coulter Electronics, Inc. GKL Class II 1984-02-10
K834372 PHA-1 PROGRAMMABLE HEMATOLOGY ANALYZ Diagnostic Technology, Inc. GKL Class II 1984-02-10
K840038 PREPAX DILUKIT PLUS Scientific Distributors, Inc. GIF Class I 1984-02-10

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