Product code LJY— Microbiology

FDA has cleared 8 devices under product code LJY between 1983 and 1999, filed by 8 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.

• 19991 clearance
• 19981 clearance
• 19971 clearance
• 19961 clearance
• 19941 clearance
• 19931 clearance
• 19901 clearance
• 19831 clearance

• Zeus Scientific, Inc.1 clearance
• Quest Intl., Inc.1 clearance
• Pharmacia Eni Diagnostics, Inc.1 clearance
• M.A. Bioproducts1 clearance
• Gull Laboratories, Inc.1 clearance
• Columbia Bioscience, Inc.1 clearance
• Biowhittaker Molecular Applications, Inc.1 clearance
• Biomerieux Vitek, Inc.1 clearance

• K991274 — MUMPS IGG ELISA TEST SYSTEMColumbia Bioscience, Inc.·1999-09-03
• K980059 — SERAQUEST MUMPS IGGQuest Intl., Inc.·1998-04-23
• K971857 — MUMPS IGG ELISA TESTYGull Laboratories, Inc.·1997-11-04
• K961204 — MUMPS IGG TESTZeus Scientific, Inc.·1996-07-18
• K925209 — MUMPS STATBiowhittaker Molecular Applications, Inc.·1994-10-14
• K923903 — VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSABiomerieux Vitek, Inc.·1993-08-09
• K897006 — PHARMACIA MUMPS IGG ELISAPharmacia Eni Diagnostics, Inc.·1990-07-26
• K830045 — MUMPSELISA TEST KITM.A. Bioproducts·1983-05-13