Product code JHR— Immunology

FDA has cleared 9 devices under product code JHR between 1984 and 2006, 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.

• 20061 clearance
• 19991 clearance
• 19961 clearance
• 19931 clearance
• 19902 clearances
• 19881 clearance
• 19871 clearance
• 19841 clearance

• Diagnostic Products Corp.3 clearances
• Pharmacia, Inc.2 clearances
• Ventrex Laboratories, Inc.1 clearance
• Techniclone Intl.1 clearance
• Roche Diagnostics1 clearance
• Boehringer Mannheim Corp.1 clearance

• K061970 — ELECSYS IGE II IMMUNOASSAYRoche Diagnostics·2006-08-31
• K984326 — ELECYS IGE ASSAYBoehringer Mannheim Corp.·1999-02-08
• K960067 — IMMILITE TOTAL IGEDiagnostic Products Corp.·1996-02-14
• K931703 — IMMULITE TOTAL IGEDiagnostic Products Corp.·1993-08-16
• K903000 — TURBO-RAST SPECIFIC IGE ASSAYVentrex Laboratories, Inc.·1990-07-31
• K901859 — COAT-A-COUNT TOTAL IGE IRMA, CATALOG #IKIE1, IKIE2Diagnostic Products Corp.·1990-05-03
• K882616 — ALTERNATE PROCEDURE, PHARMACIA IGE EIAPharmacia, Inc.·1988-08-04
• K873077 — PHARMACIA IGE EIAPharmacia, Inc.·1987-10-20
• K840103 — RADIOIMMUNOASSAY FOR TOTAL IGE HUMANTechniclone Intl.·1984-02-10