Product code LQM— Microbiology

FDA has cleared 7 devices under product code LQM between 1985 and 1993, filed by 7 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.

• 19932 clearances
• 19912 clearances
• 19891 clearance
• 19861 clearance
• 19851 clearance

• Vitek Systems, Inc.1 clearance
• Roche Diagnostic Systems, Inc.1 clearance
• Radiometer America, Inc.1 clearance
• Pasco Laboratories, Inc.1 clearance
• Biomerieux Vitek, Inc.1 clearance
• Bd Becton Dickinson Vacutainer Systems Preanalytic1 clearance
• American Micro Scan1 clearance

• K923313 — ROCHE OXI/FERM IIRoche Diagnostic Systems, Inc.·1993-04-05
• K925915 — VITEK RAPID CALL-GRAM NEGATIV IDENT CARDBiomerieux Vitek, Inc.·1993-03-23
• K912897 — SCEPTOR IDENTIFICATION SYSTEMBd Becton Dickinson Vacutainer Systems Preanalytic·1991-10-28
• K911429 — VITEK GRAM NEGATIVE IDENTIFICATION CARD, MODIFIEDVitek Systems, Inc.·1991-06-24
• K890057 — SENSITITRE AUTO ID PLATE AP80Radiometer America, Inc.·1989-06-09
• K862642 — GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANELAmerican Micro Scan·1986-09-11
• K851528 — PASCO GRAM NEGATIVE IDENTIFICATION SYSTEMPasco Laboratories, Inc.·1985-07-15