Product code JHG— Clinical Chemistry

FDA has cleared 7 devices under product code JHG between 1979 and 2006, 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.

• 20061 clearance
• 19871 clearance
• 19841 clearance
• 19821 clearance
• 19812 clearances
• 19791 clearance

• Helena Laboratories2 clearances
• Hana Biologics, Inc.2 clearances
• Irvine Scientific Sales Co., Inc.1 clearance
• Beckman Instruments, Inc.1 clearance
• Abbott Laboratories1 clearance

• K061549 — AMNIOSTAT-FLM-PGIrvine Scientific Sales Co., Inc.·2006-10-18
• K871593 — TDXR FETAL LUNG MATURITYAbbott Laboratories·1987-07-20
• K834616 — AMNIO STAT-FLM AGGLUTINATION TESTHana Biologics, Inc.·1984-05-25
• K822150 — AMNISTAT-FLMHana Biologics, Inc.·1982-10-21
• K813216 — SECURE FDI TEST KITBeckman Instruments, Inc.·1981-12-17
• K811588 — HELENA FETAL-TEK 200 METHODHelena Laboratories·1981-06-25
• K790798 — FETAL MATURITY TEST PROCEDUREHelena Laboratories·1979-06-05