Product code GIS— Hematology

FDA has cleared 13 devices under product code GIS between 1978 and 2016, filed by 13 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20161 clearance
• 20041 clearance
• 19991 clearance
• 19961 clearance
• 19941 clearance
• 19931 clearance
• 19921 clearance
• 19913 clearances
• 19882 clearances
• 19781 clearance

• Sigma Diagnostics, Inc.1 clearance
• R2 Diagnostics, Inc.1 clearance
• Panbio, Inc.1 clearance
• Pacific Hemostasis1 clearance
• Ortho Diagnostic Systems, Inc.1 clearance
• Kamiya Biomedical Co.1 clearance
• Instrumentation Laboratory CO1 clearance
• Haemachem, Inc.1 clearance
• Diazyme Laboratories1 clearance
• Diatech, Inc.1 clearance

• K143470 — Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control SetDiazyme Laboratories·2016-01-31
• K042919 — FIBROTEK FIBR2 Diagnostics, Inc.·2004-11-29
• K993482 — K-ASSAY FIBRINOGENKamiya Biomedical Co.·1999-12-06
• K963902 — QUANTITATIVE FIBRINOGEN ASSAYOrtho Diagnostic Systems, Inc.·1996-11-29
• K941001 — ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KITDiagnostic Specialties·1994-08-30
• K925494 — BIOMERIEUX HEMOLAB FIBRINOMATBiomerieux Vitek, Inc.·1993-05-18
• K923921 — IL TEST PT FIBRINOGEN HSInstrumentation Laboratory CO·1992-10-26
• K913061 — FIBRINOGEN DETERMINATION KITSigma Diagnostics, Inc.·1991-10-09
• K910636 — ABS CADKITPanbio, Inc.·1991-04-29
• K903874 — FIBRINOTEST(TM) - FIBRINOGEN ASSAYHaemachem, Inc.·1991-02-14
• K881685 — FIBRINOGENTEST-ODiatech, Inc.·1988-08-09
• K881150 — KINETIC FIBRINOGEN ASSAYBio/Data Corp.·1988-03-28
• K781880 — ASSAY KIT, THROMBO-SCREENPacific Hemostasis·1978-12-04