Product code GIF— Hematology

FDA has cleared 38 devices under product code GIF between 1976 and 1988, filed by 28 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19885 clearances
• 19871 clearance
• 19856 clearances
• 19848 clearances
• 19834 clearances
• 19823 clearances
• 19811 clearance
• 19803 clearances
• 19792 clearances
• 19782 clearances
• 19771 clearance
• 19762 clearances

• Scientific Distributors, Inc.4 clearances
• Hematology Marketing Assoc.3 clearances
• Toa Medical Electronics USA, Inc.2 clearances
• Nobel Scientific Industries, Inc.2 clearances
• Kvm Technologies, Inc.2 clearances
• Harleco2 clearances
• Abbott Diagnostics2 clearances
• Turpen Laboratory Systems, Inc.1 clearance
• Sysmex Corp.1 clearance
• Seragen Diagnostics, Inc.1 clearance

• K883989 — KVM ISOTONIC FLUSH SOLUTIONKvm Technologies, Inc.·1988-10-12
• K883990 — KVM ISOTONIC DILUENTKvm Technologies, Inc.·1988-10-12
• K882490 — HYCEL QUICK-LYSING HEMOGLOBIN REAGENTR&D Systems, Inc.·1988-07-25
• K882267 — SYSMEX QUICKLYSER-II (QLS-200A)Toa Medical Electronics USA, Inc.·1988-07-12
• K881130 — CELL-DYN ISOTONIC DILUENTAbbott Diagnostics·1988-03-31
• K873347 — CELL-DYN DIFF. SCREEN ISOTONIC DILUENTAbbott Diagnostics·1987-09-09
• K851843 — OSMOCEL 3Hematology Marketing Assoc.·1985-07-30
• K851280 — DASS PACKDass, Inc.·1985-07-05
• K851320 — SDI PREPAX DILUKIT M.Scientific Distributors, Inc.·1985-07-05
• K850239 — SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT-Toa Medical Electronics USA, Inc.·1985-04-01
• K850095 — LASER-DILHematology Marketing Assoc.·1985-03-29
• K844782 — NSI ELT-D DILUTING FLUID 4000MLNobel Scientific Industries, Inc.·1985-03-05
• K842929 — HAYEM DILUTING FLUIDE K Ind., Inc.·1984-09-07
• K842068 — IDI ISOTONIC DILUENTInterscience Diagnostics, Inc.·1984-07-02
• K841799 — CYANOMETHEMOGLOBIN REAGENTReagent Laboratory, Inc.·1984-05-31
• K840041 — SDI PREPAX DILUKIT HWScientific Distributors, Inc.·1984-03-05
• K840477 — UNITIZED HEMATOLOGY SET 65132/93Emd Chemicals, Inc.·1984-03-05
• K833972 — QUICK-COUNT HEMATOLOGY REAGENT KITSeragen Diagnostics, Inc.·1984-02-17
• K840038 — PREPAX DILUKIT PLUSScientific Distributors, Inc.·1984-02-10
• K840043 — SDI PREPAX DILUKIT CTScientific Distributors, Inc.·1984-02-10
• K833443 — ISOTONIC BLOOD CELL DILUENT J & SJasins & Sayles Associates, Inc.·1983-11-03
• K832116 — ATAC 4700 HEMATOLOGY CELL COUNTERTurpen Laboratory Systems, Inc.·1983-10-20
• K831617 — DILUENTOmega Medical Diagnostics·1983-06-16
• K830188 — OSMOCEL +Hematology Marketing Assoc.·1983-03-01
• K822325 — BLOOD CELL DILUENT 78N 1913Interscience, Inc.·1982-10-18
• K822501 — CDL ISOTONIC DILUENTConnecticut Diagnostics, Ltd.·1982-09-17
• K821683 — REAGENT FOR COULTER COUNTER MODEL 5+11Fisher Scientific Co., LLC·1982-06-24
• K812309 — CRYOSAN NORMAL SALINECryosan, Inc.·1981-09-16
• K801357 — MODIFIED BLOOD CELL COUNTING & LYSINGCoulter Electronics, Inc.·1980-08-14
• K801346 — NSI REAGENT SYSTEM FOR ORTHO ELT-8 HEMANobel Scientific Industries, Inc.·1980-08-12
• K800180 — VARIOUS REAGENTS FOR BLOOD CELL ANALYZERLaboratory Products, Inc.·1980-03-19
• K790442 — ISOTONIC DILUENTRoyco Instruments·1979-04-04
• K790028 — DILUENT, CELLENT BLOODSysmex Corp.·1979-02-15
• K781008 — ISOTONIC DILUENTMallinckrodt Critical Care·1978-06-28
• K780830 — ISOTONIC BUFFERED SALINEHarleco·1978-06-14
• K771787 — AZIDE FREE BLOOD DILUTING REAGENTJ.T. Baker Chemical Co.·1977-10-07
• K760124 — AUTO CELL DILUENTBd Becton Dickinson Vacutainer Systems Preanalytic·1976-07-20
• K760129 — SALINE, ISOTONIC BUFFERED, AZIDE-FREEHarleco·1976-07-20