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Review Panel

Hematology FDA 510(k) Clearances & Devices

Cleared Devices
4,197
Product Codes (page)
23
Latest Decision
1988-12-05

Clearances · page 24 of 42

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K884006 HEMAT 12 Texas Intl. Laboratories, Inc. GKZ Class II 1988-12-05
K884436 MODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-85 Harris Mfg. Co. KSE Class II 1988-12-02
K884623 SAFE-TEC CAPILLARY BLOOD COLLECTION TUBE Safe-Tec Clinical Products, Inc. GIO Class I 1988-12-01
K884654 ALPHACALF SERUM Hyclone Laboratories, Inc. KIT Class I 1988-11-30
K883177 H 10 OR HEMATIL 10 BLOOD CELL & PLATELET COUNTER Texas Intl. Laboratories, Inc. GKZ Class II 1988-11-30
K883836 COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II Coulter Immunology GGK Class I 1988-11-30
K883662 BERICHROM(R) ANTITHROMBIN III Behring Diagnostics, Inc. JBQ Class II 1988-11-23
K884574 DME & HAM'S NUTRIENT MIXTURE, PROD. NO. D9785 Sigma Chemical Co. KIT Class I 1988-11-22
K883850 MSI-CAL 16 Medical Specialties, Inc. KRZ Class II 1988-11-22
K884572 RPMI-1640 HYBRI-MAX, PROD. NO. R5382 Sigma Chemical Co. KIT Class I 1988-11-22
K884573 HBSS W/O CALC CHLOR/MAG SULF/PHEN RED/SB NO. H4891 Sigma Chemical Co. KIT Class I 1988-11-22
K880673 GHB SAMPLE PAPER Isolab, Inc. LCP Class II 1988-11-22
K883703 MSI-CAL 7 Medical Specialties, Inc. KRZ Class II 1988-11-22
K883851 MSI-CAL 8 Medical Specialties, Inc. KRZ Class II 1988-11-22
K883692 ORTHO FACTOR VII DEFICIENT PLASMA Ortho Diagnostic Systems, Inc. GJT Class II 1988-11-01
K883690 ORTHO FACTOR X DEFICIENT PLASMA Ortho Diagnostic Systems, Inc. GJT Class II 1988-11-01
K883689 ORTHO OWREN'S BUFFER Ortho Diagnostic Systems, Inc. JPA Class II 1988-11-01
K883688 ORTHO FACTOR XII DEFICIENT PLASMA Ortho Diagnostic Systems, Inc. GJT Class II 1988-11-01
K883691 ORTHO FACTOR XI DEFICIENT PLASMA Ortho Diagnostic Systems, Inc. GJT Class II 1988-11-01
K883635 KD 0.1 M SODIUM CITRATE SOLUTION King Diagnostics, Inc. JPA Class II 1988-10-31
K883637 KD 0.02 M CALCIUM CHLORIDE SOLUTION King Diagnostics, Inc. JPA Class II 1988-10-31
K883640 KD ONE-STAGE PROTHROMBIN TIME TEST King Diagnostics, Inc. JPA Class II 1988-10-31
K883432 IMMUNOCCULT-LXI Intl. Immunoassay Laboratories, Inc. KHE Class II 1988-10-31
K884069 SNAP N' STAIN IODINE STAIN Scientific Device Laboratory, Inc. JTS Class I 1988-10-25
K883065 ALLOPREP SYSTEM Osteotech, Inc. KIT Class I 1988-10-13
K883989 KVM ISOTONIC FLUSH SOLUTION Kvm Technologies, Inc. GIF Class I 1988-10-12
K883990 KVM ISOTONIC DILUENT Kvm Technologies, Inc. GIF Class I 1988-10-12
K883992 KVM PREPACK HEMATOLOGY REAGENT SET Kvm Technologies, Inc. GKK Class II 1988-10-12
K883991 KVM HEMOGLOBIN LYSING REAGENT Kvm Technologies, Inc. GGK Class I 1988-10-12
K883683 HEMOGLOBIN Tech-Co, Inc. GJZ Class II 1988-10-06
K884031 FBS, EQ., OR FETAL BOVINE SERUM EQUIVALENT Regency Biotech KIT Class I 1988-10-06
K884011 SNAP N' STAIN IRON STAIN Scientific Device Laboratory, Inc. GGH Class I 1988-10-06
K874180 COLORECTAL CANCER RISK DETECTOR (TM) Pearce Clinical Laboratories, Inc. KHE Class II 1988-09-30
K883951 MEDIUM 199 W/EBSS (CATALOG NO. 200-2037) J R Scientific KIT Class I 1988-09-30
K881863 REP GLYCO SYSTEM Helena Laboratories LCP Class II 1988-09-30
K882799 HELENA COLOCARE Helena Laboratories KHE Class II 1988-09-30
K883682 CHANG MEDIUM (ADDITIONAL INDICATIONS) Hana Biologics, Inc. KIT Class I 1988-09-16
K882557 COULTER CLONE B1 MONOCLONAL ANTIBODY Coulter Immunology GKZ Class II 1988-09-14
K883441 VISION(R) PROTHROMBIN TIME Abbott Laboratories GJS Class II 1988-09-13
K883626 EX-CELL 301, CATALOG NO. 210-3577 J R Scientific KIT Class I 1988-09-07
K883630 RPMI-1640 MEDIUM, CATALOG NO. 210-3525 J R Scientific KIT Class I 1988-09-07
K883629 HANK'S BALANCED SALTS (HBSS) CATALOG # 210-3013 J R Scientific KIT Class I 1988-09-07
K883632 EX-CELL 300TM, CATALOG NO. 210-3575 J R Scientific KIT Class I 1988-09-07
K883624 EX-CELL 300TM, CATALOG NO. 200-3601 J R Scientific KIT Class I 1988-09-07
K883625 EX-CELL 301, CATALOG NO. 200-3651 J R Scientific KIT Class I 1988-09-07
K883631 EX-CELL 300TM, CATALOG # 210-3579 J R Scientific KIT Class I 1988-09-07
K883628 MIN ESSENT MED EAGLE FOR SPINN CULTURE, #200-2051 J R Scientific KIT Class I 1988-09-07
K882579 HEMATRAK(R) MODEL 590 Priority Service Systems GKZ Class II 1988-09-07
K883623 EX-CELL 300TM, CATALOG NO. 200-3600 J R Scientific KIT Class I 1988-09-07
K883627 MIN ESSENT MED EAGLE, JOKLIK MOD, CAT. #200-2150 J R Scientific KIT Class I 1988-09-07
K882612 SYSTEM 9000 DIFF MODEL AUTOMATED CELL COUNTER Baker Instructions Corp. GKZ Class II 1988-09-07
K882602 STACHROM ANTIPLASMIN TEST KIT American Bioproducts Co. GGP Class II 1988-09-02
K882603 STACHROM ANTIPLASMIN CONTROL American Bioproducts Co. GGP Class II 1988-09-02
K882480 HEMOCHRON CONTROL PLASMA NORMAL/ABNORMAL LEV. I/II International Technidyne Corp. GGN Class II 1988-08-30
K883451 SFRE 199-1 MEDIUM, CATALOG NO. 200-2191 J R Scientific KIT Class I 1988-08-30
K882481 HEMOCHRON CONTROL ACT TEST TUBE NORMAL/ABNOR. I/II International Technidyne Corp. GGN Class II 1988-08-30
K883052 METHENO-STAIN KIT Scientific Device Laboratory, Inc. JTS Class I 1988-08-30
K883450 SFRE 199-2 MEDIUM, CATALOG NO. 200-2192 J R Scientific KIT Class I 1988-08-29
K883363 ISCOVE'S MODIFIED DELBECCO'S MEDIUM NO.200-2105 J R Scientific KIT Class I 1988-08-29
K883364 ISCOVE'S MODIFIED DELBECCO'S MEDIUM NO.210-3505 J R Scientific KIT Class I 1988-08-29
K883502 FETAL BOVINE SERUM, DEFINED NO. 110-1121 J R Scientific KIT Class I 1988-08-29
K883497 MEDIUM 199, 10X CATALOG NO. 210-3556 J R Scientific KIT Class I 1988-08-29
K883368 NEWBORN CALF SERUM, CATALOG NO. 110-1130 J R Scientific KIT Class I 1988-08-29
K883498 FETAL BOVINE SERUM, HEAT INACTIVATED NO.110-1123 J R Scientific KIT Class I 1988-08-29
K883369 L-15 MEDIUM, CATALOG NO. 210-4004 J R Scientific KIT Class I 1988-08-29
K883445 HANKS' BALANCED SALTS (HBSS) 10X, NO. 210-3012 J R Scientific KIT Class I 1988-08-29
K883370 FISCHER'S MEDIUM CATALOG NO. 210-4007 J R Scientific KIT Class I 1988-08-29
K883501 MCCOY'S 5A MEDIUM (CATALOG NO. 210-3531) J R Scientific KIT Class I 1988-08-29
K883367 CALF SERUM, CATALOG NO. 110-1125 J R Scientific KIT Class I 1988-08-29
K883366 MEDIUM 199, CATALOG NO. 200-2031 J R Scientific KIT Class I 1988-08-29
K883448 MINIMUM ESSENTIAL MEDIUM EAGLE NO. 200-2046 J R Scientific KIT Class I 1988-08-29
K883499 MEDIUM 199, 10X, CATALOG NO. 210-3557 J R Scientific KIT Class I 1988-08-29
K883446 FETAL BOVINE SERUM, GAMMA IRRADIATED NO. 110-1122 J R Scientific KIT Class I 1988-08-29
K883496 MINIMUM ESSENTIAL MEDIUM EAGLE (MEM), 210-3517 J R Scientific KIT Class I 1988-08-29
K883495 MEDIUM 199, 10X, CATALOG NO. 210-3555 J R Scientific KIT Class I 1988-08-29
K883449 MINIMUM ESSENTIAL MEDIUM EAGLE, NO. 200-2048 J R Scientific KIT Class I 1988-08-29
K883362 L-15 MEDIUM, CATALOG NO. 200-2021 J R Scientific KIT Class I 1988-08-29
K883500 MCCOY'S 5A MEDIUM 10X NO. 210-3532 J R Scientific KIT Class I 1988-08-29
K883365 HORSE SERUM, ABATTOIR, NO. 110-1112 J R Scientific KIT Class I 1988-08-29
K883447 MINIMUM ESSENTIAL MEDIUM EAGLE 10X, NO.210-3511 J R Scientific KIT Class I 1988-08-29
K882325 UNIFAST ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST Sclavo, Inc. GFO Class II 1988-08-25
K882370 SYSMEX K-1000 18 PARAMETER, AUTO. HEMA ANALYZER Toa Medical Electronics USA, Inc. GKZ Class II 1988-08-25
K882444 COAG-I ANALYZER, ALPHA MODEL Cardiovascular Diagnostic Services JPA Class II 1988-08-25
K883484 OWREN'S VERONAL BUFFER Helena Laboratories JPA Class II 1988-08-25
K882456 COAG-I PT TEST CARD Cardiovascular Diagnostic Services GJS Class II 1988-08-25
K883185 SAFECRIT PLASTIC MICROHEMATOCRIT TUBES Norfolk Scientific, Inc. GHY Class II 1988-08-18
K882944 DIMERTEST(R) LATEX Agen Biomedical , Ltd. DAP Class II 1988-08-17
K883061 ATS PARA-SET CARBOL-XYLENE SOLUTION Alpha-Tech Systems, Inc. JTS Class I 1988-08-17
K883049 ATS PARA-SET IODINE ALCOHOL SOLUTION Alpha-Tec Systems, Inc. JTS Class I 1988-08-17
K881999 PLATELIN(R) EXCEL L Organon Teknika Corp. GIT Class II 1988-08-17
K883139 MEDIUM 199 EBSS/NUTRIENT MIXTURE F-10 #200-2110 J R Scientific KIT Class I 1988-08-15
K883292 BOVINE SERUM, CAT. LNO. 110-1115 J R Scientific KIT Class I 1988-08-15
K883289 CALF SERUM, HEAT INACTIVATED, CAT. # 110-1127 J R Scientific KIT Class I 1988-08-15
K883140 MINIMUM ESSENTIAL MED (MEM,THERMO-POW(R)#200-2090 J R Scientific KIT Class I 1988-08-15
K883286 NEWBORN CALF SERUM, HEAT INACTIVATED # 110-1131 J R Scientific KIT Class I 1988-08-15
K883287 CALF SERUM, GAMMA IRRADIATED, CAT. NO. 110-1126 J R Scientific KIT Class I 1988-08-15
K883285 FETAL BOVINE SERUM, CAT. NO. 110-1120 J R Scientific KIT Class I 1988-08-15
K883290 DONOR BOVINE SERUM, CAT. NO. 110-1116 J R Scientific KIT Class I 1988-08-15
K883288 DONOR HORSE SERUM, HEAT INACTIVATED, #110-1113 J R Scientific KIT Class I 1988-08-15
K883291 DONOR HORSE SERUM, CAT. NO. 110-1110 J R Scientific KIT Class I 1988-08-15

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