Product code KEA— Clinical Chemistry

FDA has cleared 9 devices under product code KEA between 1978 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
• 19851 clearance
• 19841 clearance
• 19834 clearances
• 19791 clearance
• 19781 clearance

• Biosan Laboratories, Inc.2 clearances
• Syva Co.1 clearance
• Mcb Manufacturing Chemists, Inc.1 clearance
• Lkb Instruments, Inc.1 clearance
• Emd Chemicals, Inc.1 clearance
• Berwick Medical Products, Inc.1 clearance
• Atlantic Wholesale, Inc.1 clearance
• Analytichem International, Inc.1 clearance

• K890997 — ZAVOS DISPOSABLE FILTRATION COLUMN (ZDFC)Atlantic Wholesale, Inc.·1989-03-28
• K844948 — SYVA SOLID PHASE COLUMNSSyva Co.·1985-08-29
• K842028 — CM-TRISACRYL M DEAE-TRISACRYL MLkb Instruments, Inc.·1984-06-07
• K833320 — AMBERLITE CG50 RESIN, 100-200 MESHBiosan Laboratories, Inc.·1983-12-08
• K833319 — BIO-REX 70 RESIN 100-200 MESH PH6.2Biosan Laboratories, Inc.·1983-11-03
• K831027 — EXTRELUT QE EXTRACTION COLUMNSEmd Chemicals, Inc.·1983-05-16
• K830918 — I.E.C COLUMNBerwick Medical Products, Inc.·1983-04-27
• K782066 — EXETRELUTMcb Manufacturing Chemists, Inc.·1979-01-03
• K781728 — EXTUBEAnalytichem International, Inc.·1978-12-20