Product code JCA— Hematology

FDA has cleared 7 devices under product code JCA between 1977 and 1991, filed by 6 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.

• 19912 clearances
• 19871 clearance
• 19851 clearance
• 19831 clearance
• 19801 clearance
• 19771 clearance

• International Technidyne Corp.2 clearances
• Ulster Scientific, Inc.1 clearance
• Organon Teknika Corp.1 clearance
• Helena Laboratories1 clearance
• General Diagnostics1 clearance
• American Dade1 clearance

• K911745 — SIMPLATE PEDIATRICOrganon Teknika Corp.·1991-08-09
• K911996 — SURGICUTT-BLEEDING TIME DEVICE, MODIFICATIONInternational Technidyne Corp.·1991-07-17
• K871318 — Q.I.C. BLEEDING TIME DEVICEHelena Laboratories·1987-06-10
• K850542 — SURGICUTT - BLEEDING TIME DEVICEInternational Technidyne Corp.·1985-03-01
• K830645 — BLEEDING TIME DEVICE DISPOSABLEAmerican Dade·1983-03-17
• K801815 — AUTOLETUlster Scientific, Inc.·1980-10-10
• K761250 — SIMPLATEGeneral Diagnostics·1977-03-01