Product code FLB— Gastroenterology, Urology

FDA has cleared 6 devices under product code FLB between 1977 and 2010, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20101 clearance
• 19941 clearance
• 19881 clearance
• 19831 clearance
• 19821 clearance
• 19771 clearance

• Mesa Medical, Inc.2 clearances
• Western Laboratories Corp.1 clearance
• Renal Systems, Inc.1 clearance
• Myron L Company1 clearance
• Cobe Laboratories, Inc.1 clearance

• K100237 — DIALYSATE METER, MODEL D-6Myron L Company·2010-04-23
• K925210 — 90DX MULTITEST METER, MODIFICATIONMesa Medical, Inc.·1994-01-25
• K882032 — MODEL 90DX MULTITEST METERMesa Medical, Inc.·1988-08-11
• K830629 — COBE RX METERCobe Laboratories, Inc.·1983-04-06
• K821415 — MODEL 90 BCWestern Laboratories Corp.·1982-05-27
• K770263 — DIALYSATE METER RS-2100A, CIRCUIT CHANGERenal Systems, Inc.·1977-02-18