Product code LTW— Microbiology

FDA has cleared 16 devices under product code LTW between 1984 and 1985, filed by 4 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.

• 198513 clearances
• 19843 clearances

• Austin Biological Laboratories11 clearances
• Analytical Products, Inc.3 clearances
• Microtech Medical Systems, Inc.1 clearance
• Bd Becton Dickinson Vacutainer Systems Preanalytic1 clearance

• K852613 — MIC-CONCEPT SYSTEMMicrotech Medical Systems, Inc.·1985-09-20
• K853273 — PRECEPT CEFTRIAXONEAustin Biological Laboratories·1985-09-16
• K853596 — PRECEPT CEFOPERAZONEAustin Biological Laboratories·1985-09-16
• K853685 — PRECEPT TM CARBENICILLINAustin Biological Laboratories·1985-09-16
• K853772 — PRECEPT METHICILLINAustin Biological Laboratories·1985-09-16
• K853684 — PRECEPT KANAMYCINAustin Biological Laboratories·1985-09-13
• K853686 — PRECEPT TM AMIKACINAustin Biological Laboratories·1985-09-13
• K853687 — PRECEPT NETILMICIN 32-13Austin Biological Laboratories·1985-09-13
• K853688 — PRECEPT TM TOBRAMYCINAustin Biological Laboratories·1985-09-13
• K853689 — PRECEPT TM MOXALACTAMAustin Biological Laboratories·1985-09-13
• K853053 — PRECEPT ERYTHROMYCINAustin Biological Laboratories·1985-08-29
• K853263 — PRECEPT AVGMENTINAustin Biological Laboratories·1985-08-29
• K850347 — API UNISCEPT KBAnalytical Products, Inc.·1985-03-26
• K844159 — API UNISCEPT MIC 100ULAnalytical Products, Inc.·1984-12-14
• K844231 — SCEPTOR BETA-LACTAM PLUS MIC PANELBd Becton Dickinson Vacutainer Systems Preanalytic·1984-11-07
• K843733 — API UNISCEPT KBAnalytical Products, Inc.·1984-10-24