Product code CED— Clinical Chemistry

FDA has cleared 9 devices under product code CED between 1979 and 1989, filed by 8 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.

• 19891 clearance
• 19842 clearances
• 19821 clearance
• 19813 clearances
• 19801 clearance
• 19791 clearance

• Union Carbide Corp.2 clearances
• Sigma Chemical Co.1 clearance
• Sandare Chemical Co., Inc.1 clearance
• Em Diagnostic Systems, Inc.1 clearance
• Eastman Kodak Company1 clearance
• Connecticut Diagnostics, Ltd.1 clearance
• Btc Diagnostics, Inc.1 clearance
• American Monitor Corp.1 clearance

• K894288 — PHOSPHORUS TEST ITEM NUMBER 65416Em Diagnostic Systems, Inc.·1989-08-31
• K840151 — EKTACHEM CLINICAL CHEM. SLIDESEastman Kodak Company·1984-03-22
• K833710 — BTC URINE LH ASSAYBtc Diagnostics, Inc.·1984-01-30
• K820832 — PHOSPHORUS ILAmerican Monitor Corp.·1982-04-15
• K812670 — SANDARE FAST 340 PHOSPHORUS PROCEDURESandare Chemical Co., Inc.·1981-10-02
• K811864 — SIGMA PROCEDURE 265-UVSigma Chemical Co.·1981-07-31
• K811222 — INORGANIC PHOSPHORUS REAGENTSConnecticut Diagnostics, Ltd.·1981-05-21
• K802420 — CENTRIFICHEM INORGANIC PHOSPHORUSUnion Carbide Corp.·1980-10-31
• K790662 — CENTRIFICHEM INORGANIC PHOSPHORUSUnion Carbide Corp.·1979-05-15