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Review Panel

Hematology FDA 510(k) Clearances & Devices

Cleared Devices
4,197
Product Codes (page)
50
Latest Decision
1982-09-02

Clearances · page 36 of 42

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K821851 CONTROL DIAGNOSTICS PLATELET CONTROL Immunogenetics KRY Class II 1982-09-02
K822352 HEMATOXYLIN STAIN SOLUTION Fisher Scientific Co., LLC HYJ Class I 1982-08-16
K822123 ISOPROPANOL HEMOGLOBIN STABILITY TEST Helena Laboratories GKA Class II 1982-08-05
K822128 VOLU-SOL SINGLE DIFFERENTIAL STAIN Volu Sol Medical Industries ICN Class I 1982-08-05
K822038 VOLU-SOL ORANGE G-6(GILLS-MOD Volu Sol Medical Industries HZH Class I 1982-08-03
K822035 VOLU-SOL GILLS EA Volu Sol Medical Industries HZJ Class I 1982-08-03
K821956 HAEM-C PLUS BLOOD REFERENCE CONTROLS Baker Instructions Corp. JCN Class II 1982-07-30
K822045 SERALYZER HEMOGLOBIN TEST MODULE Miles Laboratories, Inc. KHG Class II 1982-07-30
K822046 SERALYZER HEMOGLOBIN CALIBRATORS Miles Laboratories, Inc. KRZ Class II 1982-07-30
K822044 SERALYZER HEMOGLOBIN REAGENT STRIPS Miles Laboratories, Inc. KHG Class II 1982-07-30
K821912 MCCOY'S POWDER MEDIUM 5A SUSPENSION Dutchland Laboratories, Inc. KIT Class I 1982-07-27
K821914 COON'S F-12 POWDER MEDIUM Dutchland Laboratories, Inc. KIT Class I 1982-07-27
K821918 POWDERED RPMI-1603 MEDIUM Dutchland Laboratories, Inc. KIT Class I 1982-07-27
K821917 WAYMOUTH'S POWDER MEDIUM Dutchland Laboratories, Inc. KIT Class I 1982-07-27
K821919 POWDERED RPMI-1634 MEDIUM Dutchland Laboratories, Inc. KIT Class I 1982-07-27
K821915 BME AUTOCLAVABLE MEDIUM Dutchland Laboratories, Inc. KIT Class I 1982-07-27
K821913 ISCOVE'S MODIFIED DULBECCO POWDER MEDIUM Dutchland Laboratories, Inc. KIT Class I 1982-07-27
K821911 S-MEM-JOKLIK'S POWDER Dutchland Laboratories, Inc. KIT Class I 1982-07-27
K821916 IMPROVED MEM-RICHTER'S POWDER MODIF. Dutchland Laboratories, Inc. KIT Class I 1982-07-27
K821963 EIA-F8 ENZYMEIMMUNOASSAY KIT FOR QUANT. Intl. Immunoassay Laboratories, Inc. GGP Class II 1982-07-27
K812906 ELVI BICLOT 816 Volu Sol Medical Industries KQG Class II 1982-07-22
K821977 GRAMSTAIN SET Granite Diagnostics, Inc. HYI Class I 1982-07-22
K820643 ORTHO SPECTRUM III & ORTHO-MUNE OK Ortho Diagnostic Systems, Inc. LIZ Class II 1982-07-14
K812728 FLEET DETECTATEST C.B. Fleet Co., Inc. KHE Class II 1982-07-02
K821575 SYSMEX CC-800 Sysmex/Toa Medical Electronics, Inc. GKL Class II 1982-07-02
K820630 QUIK-SEP HEMOGLOBIN F ASSAY & CONTROL Isolab, Inc. JPC Class II 1982-06-25
K821186 PENETRAK TM Syva Co. GKZ Class II 1982-06-25
K821658 HEMOGLOBIN REAGENT Anco Medical Reagents & Assoc. KHG Class II 1982-06-25
K821683 REAGENT FOR COULTER COUNTER MODEL 5+11 Fisher Scientific Co., LLC GIF Class I 1982-06-24
K821687 REMOVAWELL TISSUE CULTURE PLATE W/LID Dynatech Corp. KIZ Class I 1982-06-24
K821574 EOSIN Y SOLUTIN, AGUEOUS Sigma Chemical Co. HYB Class I 1982-06-10
K821541 HEMATOXYLIN III Volu Sol Medical Industries HYJ Class I 1982-06-10
K821540 HEMATOXYLIN II Volu Sol Medical Industries HYJ Class I 1982-06-10
K821533 HEMATOXYLIN I Volu Sol Medical Industries HYJ Class I 1982-06-10
K821573 EOSIN Y SOLUTION ALCHOLIC Sigma Chemical Co. HYB Class I 1982-06-09
K821503 IRIS URINE STAIN Intl. Remote Imaging Systems ICF Class I 1982-06-03
K821320 HEMATOXYLIN STAIN Sigma Chemical Co. HYJ Class I 1982-06-02
K821360 GLYCO-GEL TEST KIT Pierce Chemical Co. LCP Class II 1982-06-02
K821318 RETIC SET R&D Systems, Inc. KJN Class I 1982-06-02
K821457 HEMACOUNT WRIGHTS STAIN PACK II #55952 Accra Laboratories, Inc. IAF Class I 1982-06-01
K821005 PLATELET AGGREGATION PROFILER #PAP-4 Bio/Data Corp. JBX Class II 1982-06-01
K821238 CC-700 SEVEN PARAMETER, AUTOMATED HEMAA Dysmex GKL Class II 1982-05-28
K821038 FAST VIOLET B Dms Laboratories JTS Class I 1982-05-27
K821202 HEMOGLOBIN REAGENT SET Omega Medical Electronics GKK Class II 1982-05-24
K820731 HEMATALL-C PLUS HEMATOLOGY CONTROLS Fisher Scientific Co., LLC JPK Class II 1982-05-12
K820647 GAMMA FETAL BLEED SCREENING TEST Gamma Biologicals, Inc. LIM Class II 1982-05-12
K820712 SEPCOR UNIT COLLECTION MONITOR Separation Science Corp. KSQ Class I 1982-05-07
K821062 HEMATOXYLIN SOLUTION Sigma Chemical Co. HYJ Class I 1982-04-29
K820396 AUTOMATED BLOOD CELL SEPAR. DISP. SFTWR Pheragen Technology Corp. GKT Class II 1982-04-27
K820835 ALUMINA SILICA-ACTIVATED PARTIAL THROM Hyland Therapeutic Div., Travenol Laboratories GFO Class II 1982-04-26
K820923 DULBECCO'S PBS POWDER Dutchland Laboratories, Inc. KIP Class I 1982-04-21
K820918 HMEM POWDERED MEDIUM Dutchland Laboratories, Inc. KIT Class I 1982-04-21
K820924 HAMS F-12 POWDERED MEDIUM Dutchland Laboratories, Inc. KIT Class I 1982-04-21
K820917 L-15 POWDERED MEDIUM Dutchland Laboratories, Inc. KIT Class I 1982-04-21
K820920 MCCOY'S 5A POWDERED MEDIUM Dutchland Laboratories, Inc. KIT Class I 1982-04-21
K820925 H - BME POWDERED MEDIUM Dutchland Laboratories, Inc. KIT Class I 1982-04-21
K820929 RPMI-164POWDERED MEDIUM Dutchland Laboratories, Inc. KIT Class I 1982-04-21
K820921 D-MEM-LOW GLUCOSE-POWDERED MEDIUM Dutchland Laboratories, Inc. KIT Class I 1982-04-21
K820915 MEM AUTOCLAVABLE MEDIUM Dutchland Laboratories, Inc. KIT Class I 1982-04-21
K820914 EMEM POWERED MEDIUM Dutchland Laboratories, Inc. KIT Class I 1982-04-21
K820916 D-MEM-HIGH GLUCOSE-POWDERED MEDIUM Dutchland Laboratories, Inc. KIT Class I 1982-04-21
K820930 FISCHER'S POWDERED MEDIUM Dutchland Laboratories, Inc. KIT Class I 1982-04-21
K820922 HAMS F-10 POWDERED MEDIUM Dutchland Laboratories, Inc. KIT Class I 1982-04-21
K820927 HBS POWDER Dutchland Laboratories, Inc. KIP Class I 1982-04-21
K820928 EBS POWDER Dutchland Laboratories, Inc. KIP Class I 1982-04-21
K820926 E-BME POWDERED MEDIUM Dutchland Laboratories, Inc. KIT Class I 1982-04-21
K820931 HANK'S 199 POWDERED MEDIUM Dutchland Laboratories, Inc. KIT Class I 1982-04-21
K820919 EARLE'S-199 POWDERED MEDIUM Dutchland Laboratories, Inc. KIT Class I 1982-04-21
K820447 ALPHA PLASMA TRANSFER SET Alpha Therapeutic Corp. KSB Class II 1982-04-14
K820642 SICKLE-CHECK Panmed, Inc. GHM Class II 1982-04-14
K820368 LECTIN-A American Dade KSI Class II 1982-04-14
K813033 CLAY ADAMS QBC CENTRIFUGAL HEMOTOLOGY Bd Becton Dickinson Vacutainer Systems Preanalytic GKG Class II 1982-04-09
K820301 PLASMA POOLER HEAT SEALER North American Biologicals, Inc. KSD Class I 1982-04-09
K820518 GELMAN GLYCO-PHORE BUFFER Gelman Sciences, Inc. JBD Class II 1982-04-09
K820279 GLYCO-GEL TEST KIT Pierce Chemical Co. LCP Class II 1982-04-08
K820509 MEM VITAMINS (100X Dutchland Laboratories, Inc. KIT Class I 1982-04-08
K820532 DISPO FIBRIN PIPET TIPS B4182-2 American Scientific Products GIE Class II 1982-04-08
K820533 B4182-1 American Scientific Products GIE Class II 1982-04-08
K820787 HELENA ABNORMAL HBA2 QUIK COLUMN CONTROL Helena Laboratories JCM Class II 1982-04-08
K820573 HELENA HEMOGLOBIN DETECT COLUMN SYS Helena Laboratories GKA Class II 1982-04-01
K820437 AVES WRIGHT STAIN Helena Laboratories IAF Class I 1982-03-26
K820450 THROMBOSCREEN Pacific Hemostasis GIT Class II 1982-03-26
K820508 MEM NON-ESSENTIAL AMINO ACIDS (100X) Dutchland Laboratories, Inc. KIT Class I 1982-03-26
K820634 TRICHROME STAIN Volu Sol Medical Industries HYC Class I 1982-03-26
K820495 SODIUM PYRUVATE (100MM) Dutchland Laboratories, Inc. KIT Class I 1982-03-26
K820596 CYANMETHEMOGLOBIN TEST Boehringer Mannheim Corp. KHG Class II 1982-03-26
K820422 PLATELET AGGREGOMETERS Chrono-Log Corp. GHR Class II 1982-03-16
K820401 ORTHO* HEMATOLOGY CONTR. 8 ABN. HI/LOW Orhto Diagnostic Systems, Inc. JPK Class II 1982-03-15
K820400 ORTHO* HEMATOLOGY CONTROL 8 NORMAL Ortho Diagnostic Systems, Inc. JPK Class II 1982-03-15
K812947 MONO-POLY RESOLVING MEDIUM Flow Laboratories, Inc. JCF Class I 1982-03-11
K813489 ROCKING/CIRCULATING CYTO-THERM II 3570 Cryosan, Inc. KZL Class II 1982-03-04
K813342 GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION Gamma Biologicals, Inc. KSK Class II 1982-03-04
K820072 FE-CULT PLUS Gamma Biologicals, Inc. KHE Class II 1982-03-04
K813413 LECTIN H American Dade KSI Class II 1982-03-04
K820085 DADE FACTOR ASSAY REFERENCE PLASMA American Dade GGP Class II 1982-02-23
K813530 HEMOTOLOGY CALIBRATOR American Dade KSA Class II 1982-02-22
K820084 CLOTTING TIME REAGENT American Dade GJB Class II 1982-02-22
K820076 GLYCO-SEP REAGENT TEST SET Clin Tech Diagnostics Corp. LCP Class II 1982-02-12
K813404 FREEZE DRIED FICIN Biological Corp. of America KSK Class II 1982-02-10
K820027 MODIFIED EA 50 Surgipath HZJ Class I 1982-02-04

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