Product code CIE— Clinical Chemistry

FDA has cleared 7 devices under product code CIE between 1977 and 1990, filed by 6 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.

• 19901 clearance
• 19881 clearance
• 19871 clearance
• 19831 clearance
• 19821 clearance
• 19801 clearance
• 19771 clearance

• Hf Scientific, Inc.2 clearances
• Miles Laboratories, Inc.1 clearance
• James L. Geraci & Associates, Inc.1 clearance
• Instrumentation Laboratory CO1 clearance
• Corning Medical & Scientific1 clearance
• American Research Products Co.1 clearance

• K904761 — P/N 35310, IL TEST ALKALINE PHOSPHATASE REAGENTInstrumentation Laboratory CO·1990-11-20
• K880967 — MICRO CO2 APPARATUSHf Scientific, Inc.·1988-04-28
• K864313 — CO2 REAGENT SETHf Scientific, Inc.·1987-03-13
• K832071 — TOTAL CO2 REAGENT SETAmerican Research Products Co.·1983-08-11
• K820091 — AIRMED SMOKE EVACUATION & FILTERJames L. Geraci & Associates, Inc.·1982-02-24
• K800524 — SERALYZER REFLECTANCE PHOTOMETER/CALIB.Miles Laboratories, Inc.·1980-04-02
• K771610 — CARBON DIOXIDE ANALYZERCorning Medical & Scientific·1977-10-07