meddevicedb.com FDA Device Reference

Review Panel

Hematology FDA 510(k) Clearances & Devices

Cleared Devices
4,197
Product Codes (page)
44
Latest Decision
1979-11-05

Clearances · page 40 of 42

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K792019 PHADECODE XA INHIBITOR ASSAY Pharmaseal Div., Baxter Healthcare Corp. JBQ Class II 1979-11-05
K792055 FISHER DIAGNOSTICS HEMATOLOGY CONTROLS Fisher Scientific Co., LLC JPK Class II 1979-11-05
K791867 ROYCO MODEL 921 CELL COUNTER Royco Instruments GKL Class II 1979-11-05
K792048 LANCER COAGENT APTT KIT Sherwood Medical Co. GGW Class II 1979-11-05
K792031 LANCER COAGENT PT KIT Sherwood Medical Co. GJS Class II 1979-11-05
K791971 MONOJECT SICKLE CELL KIT Sherwood Medical Co. GHM Class II 1979-11-05
K791903 COULTER DIFF3 SYS. (COULTER #7400003) Coulter Electronics, Inc. GKZ Class II 1979-10-30
K792017 VOLU-SOL STAT STAIN Volu Sol Medical Industries IAF Class I 1979-10-30
K791673 EMPTY TRANSFER BAG Delmed, Inc. KSR Class II 1979-10-23
K791642 A-GENT GLYCOSPEC Abbott Laboratories LCP Class II 1979-10-17
K791711 IMPROVED GRAM STAIN REAGENTS Carr-Scarborough Microbiologicals, Inc. HYI Class I 1979-10-17
K791791 ORTHO ANTIBODY ENHANCEMENT SOLUTION Ortho Diagnostics, Inc. KSG Class II 1979-10-11
K791750 COUNTER-CHECK PLUS Diagnostic Technology, Inc. JPK Class II 1979-10-11
K791772 COUNTER-CHECK PLUS NORMAL, HIGH ABN. Diagnostic Technology, Inc. JPK Class II 1979-10-11
K791929 WRIGHTS RAPID STAIN Mcb Manufacturing Chemists, Inc. IAF Class I 1979-10-11
K791794 FACTOR VII DEFICIENT PLASMA Sigma Chemical Co. GGP Class II 1979-10-01
K791365 FAST FLOW #60310 Hi Chem, Inc. LCP Class II 1979-09-27
K791644 ROYCO MODEL 371 SUPER DILUTOR Royco Instruments GKH Class I 1979-09-19
K791577 ELVI 840 AGGREGOMETER Volu Sol Medical Industries JOZ Class II 1979-09-17
K791586 ELVI 818 DIGICLOT MULTISCAN Volu Sol Medical Industries JPA Class II 1979-09-17
K791587 ELVI 810 CLOTSCANNER Volu Sol Medical Industries KQG Class II 1979-09-17
K791041 HEMATRAK ABNORMAL RECOGNITION Geometric Data, Div. Smithkline Corp. GKZ Class II 1979-09-04
K790936 MODEL 114 TREONIC H150 HAEMOHEATER Vickers America Medical Corp. KZL Class II 1979-09-04
K791130 FLU-VEN TK-2 Venospital, Inc. KSB Class II 1979-09-04
K791131 FLU VEN TR-1 Venospital, Inc. KSB Class II 1979-09-04
K791358 FIBRO-TEC TEST KIT Calbiochem-Behring Corp. GHH Class II 1979-09-04
K791428 GLUCOHEMOGLOBIN CONTROL Bd Becton Dickinson Vacutainer Systems Preanalytic LCP Class II 1979-08-22
K791106 STERILE, DISPOSABLE CENTRIFUGE BOWL Travenol Laboratories, S.A. GKT Class II 1979-08-10
K791228 PARA-8 Streck Laboratories, Inc. JPK Class II 1979-08-03
K791227 PARA-7 Streck Laboratories, Inc. JPK Class II 1979-08-03
K791008 ECA (SPECIAL) HEME BUFFER Electrophoresis Corp. of America JBD Class II 1979-08-03
K791007 STAT DIFF STAIN Bioscientific KQC Class I 1979-08-03
K791290 BECKMAN B-4 TEB BUFFER KIT Beckman Instruments, Inc. JBD Class II 1979-08-03
K791226 PLATELET-CHEX PLUS Streck Laboratories, Inc. JPK Class II 1979-08-03
K791118 HLA CONTROL SERA Calbiochem-Behring Corp. LGO Class I 1979-08-03
K791022 PROTHROMBIN REFERENCE PLASMA (HUMAN) Pacific Hemostasis GJS Class II 1979-07-24
K791143 SICKLE-CELL F TEST Isolab, Inc. KQI Class II 1979-07-17
K790816 HEMATRAK MODEL 480 Geometric Data, Div. Smithkline Corp. GKZ Class II 1979-07-17
K791108 CONTEXT FILTER Geometric Data, Div. Smithkline Corp. GKZ Class II 1979-07-17
K791023 PROTHROMBIN FREE BEEF PLASMA (PFB) Pacific Hemostasis GJS Class II 1979-06-28
K791113 LOW IONIC STRENGTH SOLUTION (LISS) Hyland Therapeutic Div., Travenol Laboratories KSG Class II 1979-06-28
K791103 LEECO GLYCO-HEMOGLOBIN DIAGNOSTIC KIT Leeco Diagnostics, Inc. LCP Class II 1979-06-28
K790958 120 WELL HISTO-PLATE Dynatech Laboratories, Inc. KIZ Class I 1979-06-28
K790944 CITRATE AGAR GEL AND BUFFER SET Corning Medical & Scientific JBD Class II 1979-06-28
K791135 LYOPHILIZED G-HB QUIK COLUMN CONTROL Helena Laboratories LCP Class II 1979-06-28
K791049 SYNALON ROLLER BOTTLE Dynatech Laboratories, Inc. KJC Class I 1979-06-28
K791030 HEMOGLOBIN AF/SC ELECTROPHORESIS CONTROL Beckman Instruments, Inc. JPK Class II 1979-06-22
K790943 TRISEDTA-BORATE ELECTROPHORESIS FILM AGA Corning Medical & Scientific GHS Class II 1979-06-22
K790973 LO-ION Gamma Biologicals, Inc. KSG Class II 1979-06-15
K790826 COAGULATION ARP Helena Laboratories JPK Class II 1979-05-31
K790105 TERUMO IMUGARD Terumo America, Inc. GKT Class II 1979-05-24
K790776 DADE LOW IONIC STRENGTH SOLUITION (LISS) Dade, Baxter Travenol Diagnostics, Inc. KSG Class II 1979-05-23
K790767 IMMU-TEK AUTOMATIC CENTRIFUGE Dade, Baxter Travenol Diagnostics, Inc. KSN Class II 1979-05-23
K790249 TEST CELLS Hyland Therapeutic Div., Travenol Laboratories KSF Class II 1979-05-16
K790282 ELDONCARD Nordisk Infuser System KSZ Class II 1979-05-04
K790769 BETA/PAK Bio/Data Corp. JOZ Class II 1979-05-03
K790583 QUIK COLUMN METHODOLOGY Helena Laboratories LCP Class II 1979-04-23
K790571 QUIK-STAIN Dade, Baxter Travenol Diagnostics, Inc. IAF Class I 1979-04-23
K790415 HCP-7 Bioscientific JPK Class II 1979-04-04
K790457 HEMOGLOBIN CONTROLS Data Medical Associates, Inc. JPK Class II 1979-04-04
K790423 FACTOR V DEFICIENT Sigma Chemical Co. GGP Class II 1979-04-04
K790442 ISOTONIC DILUENT Royco Instruments GIF Class I 1979-04-04
K790525 HEMATROL S HEMATOLOGY CONTROLS Fisher Scientific Co., LLC JPK Class II 1979-04-03
K790498 LISS REAGENT Fisher Scientific Co., LLC KSG Class II 1979-04-03
K790323 COAG-A-MATE 2001 General Diagnostics JPA Class II 1979-03-21
K790346 ACTIVATOR Tri-Med, Inc. JBP Class II 1979-03-21
K790310 HEMOGLOBIN CONTROLS Electrophoresis Corp. GGM Class II 1979-03-21
K790211 DEHYDROGENOSE, GLUCOSE PHOSPHATE Sigma Chemical Co. JBL Class II 1979-03-15
K790204 PLASMA, STANDARDIZED NORMAL Dade, Baxter Travenol Diagnostics, Inc. JPA Class II 1979-03-12
K790239 PHYTOHAEMAGGLUTININ Pharmacia Fine Chemicals KIQ Class I 1979-03-08
K790029 FLUID, RHEMOX W LYSING Sysmex Corp. GGK Class I 1979-02-26
K790090 DETERMINATION OF ANTITHROMBIN III, 885 Sigma Chemical Co. JBQ Class II 1979-02-26
K790028 DILUENT, CELLENT BLOOD Sysmex Corp. GIF Class I 1979-02-15
K781479 HEPARIN ASSAY Dade, Baxter Travenol Diagnostics, Inc. KFF Class II 1979-02-15
K790042 STAIN, HEMASTAIN RETIC Geometric Data, Div. Smithkline Corp. GJH Class I 1979-02-15
K790026 ANALYZER, MODEL CC-720 Sysmex Corp. GKL Class II 1979-02-08
K781792 PRESSURIZER, EXETER CEMENT Howmedica Corp. KIZ Class I 1979-02-08
K790030 FLUID, RHEMOX-HB LYSING Sysmex Corp. GKR Class II 1979-02-08
K790046 G-HB QUIK COLUMN CONTROL Helena Laboratories LCP Class II 1979-01-26
K790025 COUNTER CHECK, H001, H002, H003 Diagnostic Technology, Inc. KSF Class II 1979-01-17
K781803 FILTER, EYRPUR DISPOSABLE LEUKOCITE Metrix Teknika, Inc. GKT Class II 1979-01-17
K782098 REAGENT, LYSING AND HEMOGLOBIN Dade, Baxter Travenol Diagnostics, Inc. GGK Class I 1979-01-17
K781781 HEPARSORB General Diagnostics GJA Class II 1979-01-10
K782050 PRINTER, TEK PRO TEK TALLY II Tekpro GKZ Class II 1979-01-03
K782100 HYCEL COUNTER 333 Hycel, Inc. GKL Class II 1979-01-03
K782102 HYCEL COUNTER 211 Hycel, Inc. GKL Class II 1979-01-03
K781969 BLOOD, HEMATOLOGY REFERENCE CONTROL Coulter Electronics, Inc. JPK Class II 1979-01-03
K782101 HYCEL COUNTER 222 Hycel, Inc. GKL Class II 1979-01-03
K781874 MYCOPLASMA ARGININI FITC (30-403-41) Flow Laboratories, Inc. KPB Class I 1978-12-20
K781875 STAIN KIT FOR CELL CULTURES (30-100-00) Flow Laboratories, Inc. KPB Class I 1978-12-20
K781896 BLOOD GROUP SUBSTANCE A,B North American Biologicals, Inc. KSX Class II 1978-12-20
K781895 BLOOD GROUP SUBSTANCE B North American Biologicals, Inc. KSX Class II 1978-12-20
K781948 COLUMN TEST, HEMOGLOBIN A Bio-Rad LCP Class II 1978-12-20
K781862 BLOOD GROUP SUBSTANCE A North American Biologicals, Inc. KSX Class II 1978-12-20
K781693 COLLAGENREAGENT HORM Hormon-Chemie Munchem Gmch JOZ Class II 1978-12-07
K781880 ASSAY KIT, THROMBO-SCREEN Pacific Hemostasis GIS Class II 1978-12-04
K781860 ASSAY, CHROMOGENIC ANTITHROMBIN III Ortho Diagnostics, Inc. JBQ Class II 1978-12-04
K781807 REAGENT, FIREFLY #395 Chrono-Log Corp. JOZ Class II 1978-11-22
K781562 HEMACHECK Vickers America Medical Corp. GKL Class II 1978-11-15
K781786 QUANTICEL HHR # L500 AND L501 Bhp Diagnostix, Inc. JPK Class II 1978-11-15

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