Product code JPJ— Hematology

FDA has cleared 3 devices under product code JPJ between 1977 and 1990, filed by 3 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.

• 19901 clearance
• 19781 clearance
• 19771 clearance

• J.T. Baker Chemical Co.1 clearance
• Hycel, Inc.1 clearance
• Bd Becton Dickinson Vacutainer Systems Preanalytic1 clearance

• K904675 — QBC SYSTEM MCHCBd Becton Dickinson Vacutainer Systems Preanalytic·1990-11-02
• K780946 — ROYCO MODEL 970 HEMATOLOGY DATA ANALYZERHycel, Inc.·1978-07-27
• K761304 — JTB 700 HEMATOLOGY ANALYZERJ.T. Baker Chemical Co.·1977-02-01