Product code DAO— Immunology

FDA has cleared 8 devices under product code DAO between 1979 and 2004, filed by 8 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.

• 20041 clearance
• 19981 clearance
• 19961 clearance
• 19851 clearance
• 19841 clearance
• 19811 clearance
• 19801 clearance
• 19791 clearance

• Roche Diagnostics Corp.1 clearance
• Kent Laboratories, Inc.1 clearance
• Helena Laboratories1 clearance
• Electro-Nucleonics Laboratories, Inc.1 clearance
• Dako Corp.1 clearance
• Boehringer Mannheim Corp.1 clearance
• Applications Lab1 clearance
• Advanced Cardiovascular Systems, Inc.1 clearance

• K040431 — ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2Roche Diagnostics Corp.·2004-03-10
• K982639 — SPIFE URINE IFEHelena Laboratories·1998-11-04
• K955908 — BOEHRINGER MANNHEIM IGM ASSAYBoehringer Mannheim Corp.·1996-02-09
• K850586 — SPQ TEST SYSTEM FOR IMMUNOGLOBULIN MApplications Lab·1985-03-14
• K841992 — MODIFICATION TO ACS CORONARY GUIDINGAdvanced Cardiovascular Systems, Inc.·1984-06-11
• K812487 — IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGMDako Corp.·1981-09-23
• K800450 — GEMENI IGM ASSAYElectro-Nucleonics Laboratories, Inc.·1980-04-24
• K790705 — ANTISERUM TO HUMAN IGMKent Laboratories, Inc.·1979-04-12