Product code JBF— Hematology

FDA has cleared 5 devices under product code JBF between 1995 and 2022, 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.

• 20221 clearance
• 20161 clearance
• 20081 clearance
• 20031 clearance
• 19951 clearance

• Sigma Diagnostics, Inc.1 clearance
• Pointe Scientific, Inc.,1 clearance
• Binax, Inc.1 clearance
• Baebies, Inc.1 clearance
• Alere Scarborough, Inc.1 clearance

• K201049 — FINDER G6PDBaebies, Inc.·2022-09-14
• K161364 — BinaxNOW G6PD TestAlere Scarborough, Inc.·2016-06-17
• K080003 — BINAXNOW G6PD TESTBinax, Inc.·2008-10-23
• K024006 — G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASEPointe Scientific, Inc.,·2003-03-31
• K933934 — GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-ASigma Diagnostics, Inc.·1995-06-29