Product code CGO— Clinical Chemistry

FDA has cleared 11 devices under product code CGO between 1977 and 1985, filed by 11 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.

• 19851 clearance
• 19812 clearances
• 19801 clearance
• 19782 clearances
• 19775 clearances

• Standard Scientific, Inc.1 clearance
• Stanbio Laboratory1 clearance
• Mallinckrodt Critical Care1 clearance
• King Diagnostics, Inc.1 clearance
• Icn Pharmaceuticals, Inc.1 clearance
• Harleco1 clearance
• Gamma Enterprises, Inc.1 clearance
• Fisher Scientific Co., LLC1 clearance
• Dilab, Inc.1 clearance
• Diagnostic Solutions, Inc.1 clearance

• K850938 — CHOLESTEROLDilab, Inc.·1985-06-25
• K811747 — KING DIAGNOSTICS CHOLESTEROL TESTKing Diagnostics, Inc.·1981-07-10
• K810090 — CHOLESTEROL REAGENTAnco Medical Reagents & Assoc.·1981-01-26
• K800682 — REAGENTS FOR DETERM. CHOLESTEROL/SERUMDiagnostic Solutions, Inc.·1980-05-28
• K781611 — CHOLESTEROL DET. IN SERUMFisher Scientific Co., LLC·1978-10-24
• K780545 — SR-PLUS DIRECT CHOLESTEROL TESTStanbio Laboratory·1978-05-26
• K772043 — ALPHA/CHOLStandard Scientific, Inc.·1977-11-28
• K771833 — CHOLESTEROLGamma Enterprises, Inc.·1977-10-18
• K771313 — CHOLESTEROL REAGENTMallinckrodt Critical Care·1977-08-03
• K771093 — UNIPAK CHOLESTEROLHarleco·1977-07-21
• K770457 — CHOLESTEROL PROCEDURE, TEKPOINT TOTALIcn Pharmaceuticals, Inc.·1977-05-03