Product code JJI— Clinical Chemistry

FDA has cleared 8 devices under product code JJI between 1977 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
• 19932 clearances
• 19791 clearance
• 19781 clearance
• 19772 clearances

• Bio-Rad2 clearances
• Abbott Laboratories2 clearances
• Olympus Corp.1 clearance
• Gilford Instrument Laboratories, Inc.1 clearance
• Biokinetix Corp.1 clearance
• Bd Becton Dickinson Vacutainer Systems Preanalytic1 clearance

• K972024 — CODA AUTOMATED EIA ANALYZERBio-Rad·1997-07-30
• K944731 — ABBOTT IMX 2 ANALYZERAbbott Laboratories·1994-12-19
• K931970 — ABBOTT IMX2 ANALYERAbbott Laboratories·1993-06-16
• K930898 — RADIAS AUTOMATED IMMUNOASSAY SYSTEMBio-Rad·1993-04-21
• K790073 — ANALYZER, IMPACT 100Gilford Instrument Laboratories, Inc.·1979-02-22
• K780972 — QUICKRATE REACTION RATE ANALYZEROlympus Corp.·1978-08-14
• K771591 — MINISTAT-S CHEMISTRY ANALYZERBiokinetix Corp.·1977-09-20
• K770401 — LDH/NADH,LDH/NADH, NAD & NAD DIAPHORASEBd Becton Dickinson Vacutainer Systems Preanalytic·1977-04-26