Product code CHS— Clinical Chemistry

FDA has cleared 6 devices under product code CHS between 1980 and 1993, 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.

• 19931 clearance
• 19911 clearance
• 19861 clearance
• 19841 clearance
• 19811 clearance
• 19801 clearance

• Technicon Instruments Corp.1 clearance
• Roche Diagnostic Systems, Inc.1 clearance
• Medical Analysis Systems, Inc.1 clearance
• Eastman Kodak Company1 clearance
• Corning Medical & Scientific1 clearance
• Amresco, Inc.1 clearance

• K926320 — REFLAB SYSTEM PACK LIQUID CO2 REAGENTMedical Analysis Systems, Inc.·1993-02-03
• K911838 — ROCHE REAGENT FOR C02Roche Diagnostic Systems, Inc.·1991-07-19
• K860660 — AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTSAmresco, Inc.·1986-03-14
• K841080 — TECHNICON RA-1000 SYS CO2Technicon Instruments Corp.·1984-05-02
• K811257 — CORNING 965 CARBON DIOXIDE ANALYZERCorning Medical & Scientific·1981-05-27
• K802376 — KODAK EKTA-CHEM CLINICAL CHEM. SLIDESEastman Kodak Company·1980-10-23