Product code JQE— Clinical Chemistry

FDA has cleared 6 devices under product code JQE between 1984 and 1997, filed by 6 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
• 19911 clearance
• 19881 clearance
• 19871 clearance
• 19841 clearance

• Sclavo, Inc.1 clearance
• J.S. Medical Assoc.1 clearance
• Eastman Kodak Company1 clearance
• E.I. Dupont DE Nemours & Co., Inc.1 clearance
• Canyon Diagnostics, Inc.1 clearance
• Benchmark Reagents1 clearance

• K970248 — CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEMCanyon Diagnostics, Inc.·1997-02-11
• K934358 — KODAK EKTACHEM DT SLIDES (FE)Eastman Kodak Company·1994-03-21
• K910672 — J&S PEDIATRIC IRON SATURATING REAGENTJ.S. Medical Assoc.·1991-04-29
• K884649 — TOTAL IRON BINDING CAPACITY TESTSclavo, Inc.·1988-12-14
• K864548 — ALFERR TIBC TUBEBenchmark Reagents·1987-02-02
• K842019 — TIBC PRETREATMENT KITE.I. Dupont DE Nemours & Co., Inc.·1984-06-22