Product code CEI— Clinical Chemistry

FDA has cleared 4 devices under product code CEI between 1983 and 2005, 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.

• 20051 clearance
• 19911 clearance
• 19901 clearance
• 19831 clearance

• Tech Intl. Co.1 clearance
• Sterling Diagnostics, Inc.1 clearance
• Randox Laboratories, Ltd.1 clearance
• Mallinckrodt Critical Care1 clearance

• K043268 — SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2Randox Laboratories, Ltd.·2005-02-15
• K914039 — SODIUM REAGENT SETSterling Diagnostics, Inc.·1991-10-31
• K902572 — SODIUM REAGENT SETTech Intl. Co.·1990-07-10
• K832552 — SODIUM TEST KITMallinckrodt Critical Care·1983-09-20