Product code FJD— Gastroenterology, Urology

FDA has cleared 4 devices under product code FJD between 1999 and 2013, filed by 3 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.

• 20131 clearance
• 20041 clearance
• 20011 clearance
• 19991 clearance

• Serim Research Corp.2 clearances
• Reprocessing Products Corp1 clearance
• Hach Company1 clearance

• K123805 — E-Z CHEK BLOOD LEAK TEST STRIPSReprocessing Products Corp·2013-03-20
• K042322 — STERICHEK BLOOD LEAK REAGENT STRIPSHach Company·2004-12-07
• K012115 — SERIM BLOOD LEAK TEST STRIP-2Serim Research Corp.·2001-11-30
• K990206 — SERIM BLOOD LEAK TEST STRIPSerim Research Corp.·1999-04-21