Product code KQI— Hematology

FDA has cleared 4 devices under product code KQI between 1979 and 1988, filed by 2 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.

• 19881 clearance
• 19812 clearances
• 19791 clearance

• Helena Laboratories3 clearances
• Isolab, Inc.1 clearance

• K880653 — HBF DILUENTHelena Laboratories·1988-04-21
• K812226 — HELENA HBF QUIPLATE CONTROLHelena Laboratories·1981-09-01
• K810475 — HELENA HEMOGLOBIN F CONTROLSHelena Laboratories·1981-03-26
• K791143 — SICKLE-CELL F TESTIsolab, Inc.·1979-07-17