Product code DEL— Immunology

FDA has cleared 5 devices under product code DEL between 1989 and 2001, filed by 4 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.

• 20011 clearance
• 19902 clearances
• 19892 clearances

• Sigma Chemical Co.2 clearances
• Roche Diagnostics Corp.1 clearance
• Medical Marketing Consultants, Inc.1 clearance
• Catachem, Inc.1 clearance

• K013278 — TINA-QUANT APOLIPOPROTEIN A-1 VER.2Roche Diagnostics Corp.·2001-11-15
• K901675 — APOLIPOPROTEIN A-I (APO A-I)Sigma Chemical Co.·1990-04-26
• K900124 — APOLIPOPROTEIN B (APO B)Sigma Chemical Co.·1990-03-02
• K895160 — ORTHO *APO A-1 ELISA TEST SYSTEMMedical Marketing Consultants, Inc.·1989-10-06
• K893885 — BACTON TM, BASIC TM, APO A-I REAGENTCatachem, Inc.·1989-06-21