Product code GKG— Hematology

FDA has cleared 11 devices under product code GKG between 1982 and 1996, filed by 9 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.

• 19962 clearances
• 19932 clearances
• 19922 clearances
• 19911 clearance
• 19891 clearance
• 19823 clearances

• Separation Technology, Inc.2 clearances
• Bd Becton Dickinson Vacutainer Systems Preanalytic2 clearances
• Stat-Spin Technologies1 clearance
• Novonx, Inc.1 clearance
• Micro Diagnostics Corp.1 clearance
• Labnet Intl., Inc.1 clearance
• Fisher Scientific Co., LLC1 clearance
• Boehringer Mannheim Corp.1 clearance
• bioMerieux, Inc.1 clearance

• K961803 — SPUNCRIT (MODEL DRC-40)Micro Diagnostics Corp.·1996-07-05
• K955795 — MULTI-CENTRIFUGENovonx, Inc.·1996-03-29
• K930415 — MICROHEMATOCRIT ROTORFisher Scientific Co., LLC·1993-03-23
• K925863 — SPUNCRITbioMerieux, Inc.·1993-02-05
• K920207 — HERMLE Z230HLabnet Intl., Inc.·1992-06-09
• K920759 — CRITSPIN MICRO-HEMATOCRITStat-Spin Technologies·1992-04-29
• K913128 — HEMATASTAT C-70BSeparation Technology, Inc.·1991-09-23
• K890849 — HEMATASTAT H-70Separation Technology, Inc.·1989-03-21
• K821803 — QBC CENTRIFUGAL HEMATOLOGY SYSTEMBd Becton Dickinson Vacutainer Systems Preanalytic·1982-09-14
• K822445 — HCT CENTRIFUGEBoehringer Mannheim Corp.·1982-09-14
• K813033 — CLAY ADAMS QBC CENTRIFUGAL HEMOTOLOGYBd Becton Dickinson Vacutainer Systems Preanalytic·1982-04-09