Product code DGP— Immunology

FDA has cleared 4 devices under product code DGP between 1984 and 1993, 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.

• 19931 clearance
• 19861 clearance
• 19842 clearances

• Sclavo, Inc.1 clearance
• Intl. Diagnostic Technology1 clearance
• Biomerieux Vitek, Inc.1 clearance
• Allergenetics1 clearance

• K931224 — VIDAS TOTAL IGE (IGE) ASSAYBiomerieux Vitek, Inc.·1993-05-20
• K863327 — IMMPULSE IGE ASSAY REAGENTSSclavo, Inc.·1986-12-03
• K842749 — FIAX TOTAL IGE TEST KITIntl. Diagnostic Technology·1984-08-28
• K842969 — ALLERGENETICS ALLER-SPECIFIC IGE SERUMAllergenetics·1984-08-28