Product code GLK— Hematology

FDA has cleared 7 devices under product code GLK between 1989 and 2013, filed by 7 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.

• 20131 clearance
• 20022 clearances
• 19971 clearance
• 19961 clearance
• 19931 clearance
• 19891 clearance

• Richmond Diagnostics, Inc.1 clearance
• Medical Specialties, Inc.1 clearance
• Johnson & Johnson Professionals, Inc.1 clearance
• Eurotrol B.V.1 clearance
• Ciba Corning Diagnostics Corp.1 clearance
• Bionostics, Inc.1 clearance
• Aalto Scientific, Ltd.1 clearance

• K121467 — EUROTROL HEMATOCRIT CONTROLEurotrol B.V.·2013-05-10
• K021924 — MEDICA EASYQC HEMATOCRIT CONTROLBionostics, Inc.·2002-06-24
• K020618 — AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROLAalto Scientific, Ltd.·2002-05-14
• K964452 — HEMATACHEKRichmond Diagnostics, Inc.·1997-02-20
• K961807 — CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4Ciba Corning Diagnostics Corp.·1996-07-26
• K924926 — MSI-HCTMedical Specialties, Inc.·1993-01-07
• K893562 — A.QC HCT LEVEL 1 AND 2Johnson & Johnson Professionals, Inc.·1989-07-14