Product code DDS— Immunology

FDA has cleared 4 devices under product code DDS between 1986 and 1997, filed by 3 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19972 clearances
• 19941 clearance
• 19861 clearance

• Beckman Instruments, Inc.2 clearances
• Incstar Corp.1 clearance
• Hemagen Diagnostics, Inc.1 clearance

• K972812 — RAICHEM PREALBUMIN SPIAHemagen Diagnostics, Inc.·1997-08-28
• K964781 — IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENTBeckman Instruments, Inc.·1997-05-09
• K934966 — SPQ PAL CONTROL LEVEL IIIncstar Corp.·1994-01-11
• K854811 — ICS PAB PREALBUMIN REAGENT TEST KITBeckman Instruments, Inc.·1986-01-24