Product code GJP— Hematology

FDA has cleared 4 devices under product code GJP between 1977 and 1988, filed by 4 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
• 19831 clearance
• 19772 clearances

• Medical Specialties, Inc.1 clearance
• Fisher Scientific Co., LLC1 clearance
• Dade, Baxter Travenol Diagnostics, Inc.1 clearance
• Bd Becton Dickinson Vacutainer Systems Preanalytic1 clearance

• K880608 — MSI-PCMedical Specialties, Inc.·1988-03-21
• K823930 — HEMATOLOGY QUALITY CONTROL MIXTUREFisher Scientific Co., LLC·1983-02-01
• K771588 — PLATELET CONTROLS NORMAL & ABNORMALDade, Baxter Travenol Diagnostics, Inc.·1977-08-25
• K770655 — LATELET DETERMIBATION KIT, UL 800Bd Becton Dickinson Vacutainer Systems Preanalytic·1977-06-24