Atlas FDA

Hematology

4,194 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II (K883836)Coulter Immunology1988-11-30
H 10 OR HEMATIL 10 BLOOD CELL & PLATELET COUNTER (K883177)Texas Intl. Laboratories, Inc.1988-11-30
ALPHACALF SERUM (K884654)Hyclone Laboratories, Inc.1988-11-30
BERICHROM(R) ANTITHROMBIN III (K883662)Behring Diagnostics, Inc.1988-11-23
GHB SAMPLE PAPER (K880673)Isolab, Inc.1988-11-22
MSI-CAL 16 (K883850)Medical Specialties, Inc.1988-11-22
HBSS W/O CALC CHLOR/MAG SULF/PHEN RED/SB NO. H4891 (K884573)Sigma Chemical Co.1988-11-22
MSI-CAL 7 (K883703)Medical Specialties, Inc.1988-11-22
RPMI-1640 HYBRI-MAX, PROD. NO. R5382 (K884572)Sigma Chemical Co.1988-11-22
MSI-CAL 8 (K883851)Medical Specialties, Inc.1988-11-22
DME & HAM'S NUTRIENT MIXTURE, PROD. NO. D9785 (K884574)Sigma Chemical Co.1988-11-22
ORTHO FACTOR XII DEFICIENT PLASMA (K883688)Ortho Diagnostic Systems, Inc.1988-11-01
ORTHO OWREN'S BUFFER (K883689)Ortho Diagnostic Systems, Inc.1988-11-01
ORTHO FACTOR XI DEFICIENT PLASMA (K883691)Ortho Diagnostic Systems, Inc.1988-11-01
ORTHO FACTOR X DEFICIENT PLASMA (K883690)Ortho Diagnostic Systems, Inc.1988-11-01
ORTHO FACTOR VII DEFICIENT PLASMA (K883692)Ortho Diagnostic Systems, Inc.1988-11-01
KD 0.1 M SODIUM CITRATE SOLUTION (K883635)King Diagnostics, Inc.1988-10-31
KD 0.02 M CALCIUM CHLORIDE SOLUTION (K883637)King Diagnostics, Inc.1988-10-31
KD ONE-STAGE PROTHROMBIN TIME TEST (K883640)King Diagnostics, Inc.1988-10-31
IMMUNOCCULT-LXI (K883432)Intl. Immunoassay Laboratories, Inc.1988-10-31
SNAP N' STAIN IODINE STAIN (K884069)Scientific Device Laboratory, Inc.1988-10-25
ALLOPREP SYSTEM (K883065)Osteotech, Inc.1988-10-13
KVM HEMOGLOBIN LYSING REAGENT (K883991)Kvm Technologies, Inc.1988-10-12
KVM ISOTONIC FLUSH SOLUTION (K883989)Kvm Technologies, Inc.1988-10-12
KVM ISOTONIC DILUENT (K883990)Kvm Technologies, Inc.1988-10-12
KVM PREPACK HEMATOLOGY REAGENT SET (K883992)Kvm Technologies, Inc.1988-10-12
HEMOGLOBIN (K883683)Tech-Co, Inc.1988-10-06
FBS, EQ., OR FETAL BOVINE SERUM EQUIVALENT (K884031)Regency Biotech1988-10-06
SNAP N' STAIN IRON STAIN (K884011)Scientific Device Laboratory, Inc.1988-10-06
COLORECTAL CANCER RISK DETECTOR (TM) (K874180)Pearce Clinical Laboratories, Inc.1988-09-30
REP GLYCO SYSTEM (K881863)Helena Laboratories1988-09-30
MEDIUM 199 W/EBSS (CATALOG NO. 200-2037) (K883951)J R Scientific1988-09-30
HELENA COLOCARE (K882799)Helena Laboratories1988-09-30
CHANG MEDIUM (ADDITIONAL INDICATIONS) (K883682)Hana Biologics, Inc.1988-09-16
COULTER CLONE B1 MONOCLONAL ANTIBODY (K882557)Coulter Immunology1988-09-14
VISION(R) PROTHROMBIN TIME (K883441)Abbott Laboratories1988-09-13
SYSTEM 9000 DIFF MODEL AUTOMATED CELL COUNTER (K882612)Baker Instructions Corp.1988-09-07
EX-CELL 301, CATALOG NO. 200-3651 (K883625)J R Scientific1988-09-07
EX-CELL 300TM, CATALOG NO. 200-3601 (K883624)J R Scientific1988-09-07
HEMATRAK(R) MODEL 590 (K882579)Priority Service Systems1988-09-07
MIN ESSENT MED EAGLE FOR SPINN CULTURE, #200-2051 (K883628)J R Scientific1988-09-07
MIN ESSENT MED EAGLE, JOKLIK MOD, CAT. #200-2150 (K883627)J R Scientific1988-09-07
HANK'S BALANCED SALTS (HBSS) CATALOG # 210-3013 (K883629)J R Scientific1988-09-07
EX-CELL 300TM, CATALOG # 210-3579 (K883631)J R Scientific1988-09-07
EX-CELL 300TM, CATALOG NO. 200-3600 (K883623)J R Scientific1988-09-07
EX-CELL 300TM, CATALOG NO. 210-3575 (K883632)J R Scientific1988-09-07
EX-CELL 301, CATALOG NO. 210-3577 (K883626)J R Scientific1988-09-07
RPMI-1640 MEDIUM, CATALOG NO. 210-3525 (K883630)J R Scientific1988-09-07
STACHROM ANTIPLASMIN TEST KIT (K882602)American Bioproducts Co.1988-09-02
STACHROM ANTIPLASMIN CONTROL (K882603)American Bioproducts Co.1988-09-02
HEMOCHRON CONTROL PLASMA NORMAL/ABNORMAL LEV. I/II (K882480)International Technidyne Corp.1988-08-30
HEMOCHRON CONTROL ACT TEST TUBE NORMAL/ABNOR. I/II (K882481)International Technidyne Corp.1988-08-30
METHENO-STAIN KIT (K883052)Scientific Device Laboratory, Inc.1988-08-30
SFRE 199-1 MEDIUM, CATALOG NO. 200-2191 (K883451)J R Scientific1988-08-30
L-15 MEDIUM, CATALOG NO. 200-2021 (K883362)J R Scientific1988-08-29
L-15 MEDIUM, CATALOG NO. 210-4004 (K883369)J R Scientific1988-08-29
FISCHER'S MEDIUM CATALOG NO. 210-4007 (K883370)J R Scientific1988-08-29
ISCOVE'S MODIFIED DELBECCO'S MEDIUM NO.200-2105 (K883363)J R Scientific1988-08-29
ISCOVE'S MODIFIED DELBECCO'S MEDIUM NO.210-3505 (K883364)J R Scientific1988-08-29
MINIMUM ESSENTIAL MEDIUM EAGLE, NO. 200-2048 (K883449)J R Scientific1988-08-29
CALF SERUM, CATALOG NO. 110-1125 (K883367)J R Scientific1988-08-29
HANKS' BALANCED SALTS (HBSS) 10X, NO. 210-3012 (K883445)J R Scientific1988-08-29
MINIMUM ESSENTIAL MEDIUM EAGLE (MEM), 210-3517 (K883496)J R Scientific1988-08-29
MCCOY'S 5A MEDIUM (CATALOG NO. 210-3531) (K883501)J R Scientific1988-08-29
FETAL BOVINE SERUM, DEFINED NO. 110-1121 (K883502)J R Scientific1988-08-29
MINIMUM ESSENTIAL MEDIUM EAGLE NO. 200-2046 (K883448)J R Scientific1988-08-29
FETAL BOVINE SERUM, HEAT INACTIVATED NO.110-1123 (K883498)J R Scientific1988-08-29
FETAL BOVINE SERUM, GAMMA IRRADIATED NO. 110-1122 (K883446)J R Scientific1988-08-29
MEDIUM 199, 10X CATALOG NO. 210-3556 (K883497)J R Scientific1988-08-29
HORSE SERUM, ABATTOIR, NO. 110-1112 (K883365)J R Scientific1988-08-29
MEDIUM 199, 10X, CATALOG NO. 210-3557 (K883499)J R Scientific1988-08-29
MCCOY'S 5A MEDIUM 10X NO. 210-3532 (K883500)J R Scientific1988-08-29
SFRE 199-2 MEDIUM, CATALOG NO. 200-2192 (K883450)J R Scientific1988-08-29
MEDIUM 199, 10X, CATALOG NO. 210-3555 (K883495)J R Scientific1988-08-29
NEWBORN CALF SERUM, CATALOG NO. 110-1130 (K883368)J R Scientific1988-08-29
MEDIUM 199, CATALOG NO. 200-2031 (K883366)J R Scientific1988-08-29
MINIMUM ESSENTIAL MEDIUM EAGLE 10X, NO.210-3511 (K883447)J R Scientific1988-08-29
COAG-I PT TEST CARD (K882456)Cardiovascular Diagnostic Services1988-08-25
COAG-I ANALYZER, ALPHA MODEL (K882444)Cardiovascular Diagnostic Services1988-08-25
SYSMEX K-1000 18 PARAMETER, AUTO. HEMA ANALYZER (K882370)Toa Medical Electronics USA, Inc.1988-08-25
OWREN'S VERONAL BUFFER (K883484)Helena Laboratories1988-08-25
UNIFAST ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST (K882325)Sclavo, Inc.1988-08-25
SAFECRIT PLASTIC MICROHEMATOCRIT TUBES (K883185)Norfolk Scientific, Inc.1988-08-18
PLATELIN(R) EXCEL L (K881999)Organon Teknika Corp.1988-08-17
DIMERTEST(R) LATEX (K882944)Agen Biomedical , Ltd.1988-08-17
ATS PARA-SET CARBOL-XYLENE SOLUTION (K883061)Alpha-Tech Systems, Inc.1988-08-17
ATS PARA-SET IODINE ALCOHOL SOLUTION (K883049)Alpha-Tec Systems, Inc.1988-08-17
DONOR HORSE SERUM, CAT. NO. 110-1110 (K883291)J R Scientific1988-08-15
CMRL 1969 MAINTENANCE MEDIUM CAT, # 200-2177 (K883138)J R Scientific1988-08-15
RPMI-1640 W/25MM HEPES BUFF W/O SOD BICAR 200-2120 (K883141)J R Scientific1988-08-15
NEWBORN CALF SERUM, HEAT INACTIVATED # 110-1131 (K883286)J R Scientific1988-08-15
DONOR BOVINE SERUM, CAT. NO. 110-1116 (K883290)J R Scientific1988-08-15
MEDIUM 199 EBSS/NUTRIENT MIXTURE F-10 #200-2110 (K883139)J R Scientific1988-08-15
CALF SERUM, GAMMA IRRADIATED, CAT. NO. 110-1126 (K883287)J R Scientific1988-08-15
DONOR HORSE SERUM, HEAT INACTIVATED, #110-1113 (K883288)J R Scientific1988-08-15
FETAL BOVINE SERUM, CAT. NO. 110-1120 (K883285)J R Scientific1988-08-15
MINIMUM ESSENTIAL MED (MEM,THERMO-POW(R)#200-2090 (K883140)J R Scientific1988-08-15
BOVINE SERUM, CAT. LNO. 110-1115 (K883292)J R Scientific1988-08-15
CALF SERUM, HEAT INACTIVATED, CAT. # 110-1127 (K883289)J R Scientific1988-08-15
SNAP(R) CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KIT (K874544)Molecular Biosystems, Inc.1988-08-12
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