meddevicedb.com FDA Device Reference

Review Panel

Hematology FDA 510(k) Clearances & Devices

Cleared Devices
4,197
Product Codes (page)
23
Latest Decision
1988-08-15

Clearances · page 25 of 42

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K883138 CMRL 1969 MAINTENANCE MEDIUM CAT, # 200-2177 J R Scientific KIT Class I 1988-08-15
K883141 RPMI-1640 W/25MM HEPES BUFF W/O SOD BICAR 200-2120 J R Scientific KIT Class I 1988-08-15
K874749 BINAX EQUATE GLYCOHEMOGLOBIN Binax, Inc. LCP Class II 1988-08-12
K874544 SNAP(R) CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KIT Molecular Biosystems, Inc. LGO Class I 1988-08-12
K881685 FIBRINOGENTEST-O Diatech, Inc. GIS Class II 1988-08-09
K883217 SCHIFF REAGENT Surgipath Medical Industries, Inc. HZT Class I 1988-08-05
K882991 NUTRIENT MIXTURE F-12 (HAT VARIATION) NO. 200-2070 J R Scientific KIT Class I 1988-08-04
K882992 MINIMUM ESSENTIAL MEDIUM, ALPHA MODI. NO.200-2091 J R Scientific KIT Class I 1988-08-04
K882985 FISCHER'S MEDIUM NO. 200-2184 J R Scientific KIT Class I 1988-08-04
K882997 (DME/F-12 1:1), CATALOG NO. 200-2100 J R Scientific KIT Class I 1988-08-04
K882994 DULBECCO'S PHOSPHATE BUFFERED SALINE NO. 210-3021 J R Scientific KIT Class I 1988-08-04
K882990 RPMI-1640 BAKER'S MODIFICATION NO. 200-2078 J R Scientific KIT Class I 1988-08-04
K882983 MEDIUM 199, CATALOG NO. 210-3535 J R Scientific KIT Class I 1988-08-04
K882995 FISCHER'S MEDIUM NO. 200-2188 J R Scientific KIT Class I 1988-08-04
K882986 MCCOY'S 5A MEDIUM NO. 210-3530 J R Scientific KIT Class I 1988-08-04
K882988 DULBECCO'S MODIFIED EAGLE'S MEDIUM NO. 210-3540 J R Scientific KIT Class I 1988-08-04
K882965 KREBS-HENSELEIT BICARBONATE BUFFER NO. K3753 Sigma Chemical Co. KIT Class I 1988-08-04
K882996 DULBECCO'S PHOSPHATE BUFFERED SALINE NO.210-3022 J R Scientific KIT Class I 1988-08-04
K882984 MEDIUM 199, NO. 200-2035 J R Scientific KIT Class I 1988-08-04
K882993 NUTRIENT MIXTURE F-12 (HAM) NO. 200-2071 J R Scientific KIT Class I 1988-08-04
K882989 DULBECCO'S MODIFIED EAGLE'S MEDIUM NO. 210-3502 J R Scientific KIT Class I 1988-08-04
K882987 DULBECCO'S MODIFIED EAGLE'S MEDIUM NO. 200-2009 J R Scientific KIT Class I 1988-08-04
K882222 DETERMIN HEMOGLOBIN ALC/HI PERF LIQ CHROMATOGRAPHY Bio-Rad LCP Class II 1988-08-01
K882051 BIO-RAD HEMOGLOBIN DETECTOR Bio-Rad LCP Class II 1988-08-01
K882837 DULBECCO'S MODIFIED EAGLE'S MEDIUM, NO. 200-2183 J R Scientific KIT Class I 1988-08-01
K882850 NUTRIENT MIXTURE F-10 (HAM) NO. 210-3550 J R Scientific KIT Class I 1988-08-01
K882848 RPMI-1640 MEDIUM, CATALOG NO. 210-3521 J R Scientific KIT Class I 1988-08-01
K882863 MINIMUM ESSENTIAL MEDIUM EAGLE (MEM) NO. 210-3512 J R Scientific KIT Class I 1988-08-01
K882851 RPMI-1640 MEDIUM, CATALOG NO. 210-3523 J R Scientific KIT Class I 1988-08-01
K882854 MEDIUM 199, CATALOG NO. 210-3536 J R Scientific KIT Class I 1988-08-01
K882846 DULBECCO'S MODIFIED EAGLE'S MEDIUM NO. 210-3501 J R Scientific KIT Class I 1988-08-01
K882860 MINIMUM ESSENTIAL MEDIUM EAGLE NO. 210-3510 J R Scientific KIT Class I 1988-08-01
K882853 RPMI-1640 MEDIUM, CATALOG NO. 210-3520 J R Scientific KIT Class I 1988-08-01
K882849 DULBECCO'S MODIFIED EAGLE'S MEDIUM NO. 210-3500 J R Scientific KIT Class I 1988-08-01
K882861 MINIMUM ESSENTIAL MEDIUM EAGLE NO. 210-3514 J R Scientific KIT Class I 1988-08-01
K882847 MINIMUM ESSENTIAL MEDIUM EAGLE NO. 210-3515 J R Scientific KIT Class I 1988-08-01
K882843 HANK'S BALANCED SALTS NO. 200-2515 J R Scientific KIT Class I 1988-07-28
K882864 HANKS' BALANCED SALT SOLUTION (HBSS) NO. 210-3011 J R Scientific KIT Class I 1988-07-28
K882862 DULBECCO'S PHOSPHATE BUFFERED SALINE NO. 200-2530 J R Scientific KIT Class I 1988-07-28
K882865 DULBECCO'S PHOSPHATE BUFFERED SALINE NO. 210-3025 J R Scientific KIT Class I 1988-07-28
K882866 EARLE'S BALANCED SALT SOLUTION (EBSS) NO. 210-3000 J R Scientific KIT Class I 1988-07-28
K882859 DULBECCO'S PHOSPHATE BUFFERED SALINE NO. 210-3020 J R Scientific KIT Class I 1988-07-28
K882873 FIELDTEX HEMATOXYLIN Anatech, Ltd. KQC Class I 1988-07-28
K882840 HANK'S BALANCED SALTS (HBSS) NO. 200-2520 J R Scientific KIT Class I 1988-07-28
K882842 EARLE'S BALANCED SALTS (EBSS) NO. 200-2505 J R Scientific KIT Class I 1988-07-28
K882845 EARLE'S BALANCED SALTS NO. 200-2500 J R Scientific KIT Class I 1988-07-28
K882857 HANKS' BALANCED SALTS NO. 210-3010 J R Scientific KIT Class I 1988-07-28
K882852 DULBECCO'S PHOSPHATE BUFFERED SALINE, NO 200-2525 J R Scientific KIT Class I 1988-07-28
K882856 EARLE'S BALANCED SALT SOLUTION NO. 210-3005 J R Scientific KIT Class I 1988-07-28
K882841 HANK'S BALANCED SALTS (HBSS) NO. 200-2521 J R Scientific KIT Class I 1988-07-28
K882844 HANK'S BALANCED SALTS NO. 200-2510 J R Scientific KIT Class I 1988-07-28
K882839 EARLE'S BALANCED SALTS (EBSS) NO. 200-2506 J R Scientific KIT Class I 1988-07-28
K882858 NUTRIENT MIXTURE F-12 (HAM), NO. 210-3551 J R Scientific KIT Class I 1988-07-28
K882855 HANKS' BALANCED SALT SOLUTION NO. 210-3015 J R Scientific KIT Class I 1988-07-28
K882838 MINIMUM ESSENTIAL MEDIUM EAGLE, NO. 200-2180 J R Scientific KIT Class I 1988-07-28
K882490 HYCEL QUICK-LYSING HEMOGLOBIN REAGENT R&D Systems, Inc. GIF Class I 1988-07-25
K882790 MINIMUM ESSENTIAL MEDIUM EAGLE, NO. 200-2042 J R Scientific KIT Class I 1988-07-19
K882788 MINIMUM ESSENTIAL MEDIUM EAGLE NO. 200-2047 J R Scientific KIT Class I 1988-07-19
K882775 DULBECCO'S MODIFIED EAGLE'S MEDIUM, NO. 200-2023 J R Scientific KIT Class I 1988-07-19
K882778 BASAL MEDIUM EAGEL, CATALOG NO. 200-2044 J R Scientific KIT Class I 1988-07-19
K882776 DULBECCO'S MODIFIED EAGLE'S MEDIUM, NO. 200-2014 J R Scientific KIT Class I 1988-07-19
K882781 RPMI-1640 MEDIUM, CATALOG NO. 200-2077 J R Scientific KIT Class I 1988-07-19
K882777 DULBECCO'S MODIFIED EAGLE'S MEDIUM, NO. 200-2004 J R Scientific KIT Class I 1988-07-19
K882786 RPMI-1640 CATALOG NO. 200-2079 J R Scientific KIT Class I 1988-07-19
K882785 DULBECCO'S MODIFIED EAGLE'S MEDIUM NO. 200-2006 J R Scientific KIT Class I 1988-07-19
K882783 BASAL MEDIUM EAGLE (BME) DIPLOID, NO. 200-2043 J R Scientific KIT Class I 1988-07-19
K882774 DULBECCO'S MODIFIED EAGLE'S MEDIUM, NO. 200-2002 J R Scientific KIT Class I 1988-07-19
K882780 NUTRIENT MIXTURE F-10 (HAM), NO. 200-2061 J R Scientific KIT Class I 1988-07-19
K882782 RPMI-1640 MEDIUM, CATALOG NO. 200-2081 J R Scientific KIT Class I 1988-07-19
K882779 BASAL MEDIUM EAGLE CATALOG NO. 200-2052 J R Scientific KIT Class I 1988-07-19
K882787 DULBECCO'S MODIFIED EAGLE'S MEDIUM NO. 200-2019 J R Scientific KIT Class I 1988-07-19
K882784 RPMI-1640 CATALOG NO. 200-2121 J R Scientific KIT Class I 1988-07-19
K882806 MEDIUM 199, CATALOG NO. 200-2032 J R Scientific KIT Class I 1988-07-18
K882807 DULBECCO'S MODIFIED EAGLE'S MEDIUM NO. 200-2011 J R Scientific KIT Class I 1988-07-18
K882600 HEMOCUE HEMOGLOBIN CALIBRATOR React and Co. KRZ Class II 1988-07-18
K882789 COON'S MEDIUM F-12, CATALOG NO. 200-2066 J R Scientific KIT Class I 1988-07-18
K882773 MCCOY'S 5A MEDIUM, CATA NO. 200-2026 J R Scientific KIT Class I 1988-07-18
K882767 SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM Toa Medical Electronics USA, Inc. GKH Class I 1988-07-18
K882808 RPMI-1640 MEDIUM, CATALOG NO. 200-2076 J R Scientific KIT Class I 1988-07-18
K882267 SYSMEX QUICKLYSER-II (QLS-200A) Toa Medical Electronics USA, Inc. GIF Class I 1988-07-12
K881907 HEMAGEL(TM) TEST FOR FECAL OCCULT BLOOD Enzo Biochem, Inc. KHE Class II 1988-07-08
K871143 IMMUNOCCULT EIA TEST KIT Intl. Immunoassay Laboratories, Inc. KHE Class II 1988-07-08
K881829 PAT PLATELET AGGREGATION TEST Streck Laboratories, Inc. JBX Class II 1988-07-01
K881037 SPECTROLYSE/FIBRIN Cytrx Biopool, Ltd. GGP Class II 1988-07-01
K882214 SIMPLASTIN EXCEL S Organon Teknika Corp. GJS Class II 1988-07-01
K882101 HEMOGLOBIN SCREENING DEVICE Portable Medical Laboratories, Inc. KSL Class I 1988-07-01
K881367 ACL SYSTEMS 100, 200, 300 AND 300+ COAGULATION SYS Instrumentation Laboratory CO JPA Class II 1988-06-27
K880353 CIBA CORNING MODEL 280 PH/BLOOD GAS SYSTEM Ciba Corning Diagnostics Corp. GKR Class II 1988-06-15
K880499 HEMOCCULT SENSITIVE TEST Smithkline Diagnostics, Inc. KHE Class II 1988-05-23
K881281 COAG-A-MATE(R) XM Organon Teknika Corp. GKP Class II 1988-05-18
K881186 MICROHEMATOCRIT TUBES, HEPARIN & MICROHEMA TUBE,PL Helps Products, Inc. GHY Class II 1988-05-13
K880989 ATS CRYPTOSPORIDIUM STAIN SET Alpha-Tec Systems, Inc. JTS Class I 1988-05-13
K874482 REVISED IMMUDIA HEM-SP Schiff & Co. KHE Class II 1988-05-13
K881262 CARAWAY TUBES, HEPARIN AND PLAIN Helps Products, Inc. GIO Class I 1988-05-06
K881510 CLP ABNORMAL COAGULATION CONTROL Creative Laboratory Products, Inc. GGC Class II 1988-05-06
K880698 TITAN GEL-PC GLYCO-HEME(TM) SYSTEM Helena Laboratories LCP Class II 1988-05-06
K881187 NATELSON TUBES, HEPARIN AND PLAIN Helps Products, Inc. GIO Class I 1988-05-06
K880712 CLP NORMAL COAGULATION CONTROL Creative Laboratory Products, Inc. GIZ Class II 1988-05-06
K881598 SDL TRICHROME STAIN Scientific Device Laboratory, Inc. JTS Class I 1988-05-04
K881348 VERIFY(R) REFERENCE PLASMA Organon Teknika Corp. GGN Class II 1988-05-02

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