Product code DAH— Immunology

FDA has cleared 7 devices under product code DAH between 1986 and 1993, filed by 5 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
• 19911 clearance
• 19901 clearance
• 19882 clearances
• 19862 clearances

• Helena Laboratories3 clearances
• Technicon Instruments Corp.1 clearance
• Orion Diagnostica, Inc.1 clearance
• Dako Corp.1 clearance
• Abbott Laboratories1 clearance

• K931247 — TITAN GEL IMMUNOFIX-9 CAT. NO. 3051 AND 3067Helena Laboratories·1993-04-27
• K905149 — TITAN GELHelena Laboratories·1991-01-03
• K901805 — REP(R) IMMUNOFIXHelena Laboratories·1990-06-06
• K884074 — IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN GOrion Diagnostica, Inc.·1988-10-27
• K883494 — TECHNICON DPA-1 IMMUNOGLOBULIN GTechnicon Instruments Corp.·1988-09-07
• K854944 — TDX IMMUNOGLOBULIN M DIAGNOSTIC KITAbbott Laboratories·1986-08-27
• K862184 — DAKO ITA, IMMUNOGLOBULIN M (IGM)Dako Corp.·1986-08-19