Product code CGF— Clinical Chemistry

FDA has cleared 4 devices under product code CGF between 1984 and 1997, filed by 3 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.

• 19971 clearance
• 19941 clearance
• 19871 clearance
• 19841 clearance

• Diagnostic Systems Laboratories, Inc.2 clearances
• Diagnostics Biochem Canada, Inc.1 clearance
• Corning Medical & Scientific1 clearance

• K970915 — DSL ESTRONE-SULFATE RIADiagnostic Systems Laboratories, Inc.·1997-05-16
• K935013 — DSL ESTRONE (DSL 8700)Diagnostic Systems Laboratories, Inc.·1994-06-16
• K864966 — ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONEDiagnostics Biochem Canada, Inc.·1987-01-09
• K833406 — IMMOPHASE D-TE 3 RADIOIMMUNOASSAYCorning Medical & Scientific·1984-01-24