Product code LKT— Microbiology

FDA has cleared 23 devices under product code LKT between 1983 and 2008, filed by 18 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.

• 20081 clearance
• 19991 clearance
• 19942 clearances
• 19913 clearances
• 19891 clearance
• 19882 clearances
• 19875 clearances
• 19862 clearances
• 19853 clearances
• 19842 clearances
• 19831 clearance

• Ortho Diagnostic Systems, Inc.2 clearances
• Gull Laboratories, Inc.2 clearances
• Genetic Systems Corp.2 clearances
• Diagnostic Products Corp.2 clearances
• Baxter Diagnostics, Inc.2 clearances
• Vitek Systems, Inc.1 clearance
• Sita, Inc.1 clearance
• Serono Diagnostics, Inc.1 clearance
• Neogenex1 clearance
• Microscan Div. Baxter Healthcare Corp.1 clearance

• K081928 — D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KITDiagnostic Hybrids, Inc.·2008-12-23
• K983336 — PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1Diagnostic Products Corp.·1999-03-18
• K943317 — PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV)Diagnostic Products Corp.·1994-12-19
• K942173 — RSV ANTIGEN TESTNeogenex·1994-06-30
• K912842 — RSV-MAB TESTGull Laboratories, Inc.·1991-12-09
• K912838 — BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNOBaxter Diagnostics, Inc.·1991-09-27
• K912371 — BIOMERIEUX RSV DIRECT IF KITVitek Systems, Inc.·1991-09-23
• K894623 — RESPIRATORY SYNCYTIAL VIRUSBion Ent., Ltd.·1989-10-16
• K884192 — RSV IFA TEST KIT FOR DIRECT ANTIGEN DETECTIONBaxter Diagnostics, Inc.·1988-11-22
• K882687 — ANTI-RESPIRATORY SYNCYTIAL VIRUS ANTIBODY TESTGull Laboratories, Inc.·1988-08-30
• K873564 — GENETIC SYSTEMS RSV REAGENT CONTROL SLIDESGenetic Systems Corp.·1987-11-20
• K872701 — RESPIRATORY SYNCYTIAL VIRUS CF ANTIGEN & CONTROLSita, Inc.·1987-09-18
• K872082 — RESPIRATORY SYNCYTIAL VIRUS CONTROL SLIDEMedical Diagnostic Technologies, Inc.·1987-07-31
• K870176 — GENETIC SYSTEMS RSV IMMUNOFLUORESCENCE TEST KITGenetic Systems Corp.·1987-07-16
• K871230 — ANTIBODY ASSAY FOR DETEC. OF RESP. SYNCYTIAL VIRUSMicroscan Div. Baxter Healthcare Corp.·1987-06-26
• K862321 — CELLMATICS RSV DETECTION SYSTEMDifco Laboratories, Inc.·1986-08-21
• K861379 — MONABRITE RESPIR SYNCYTIAL VIRUS(RSV) TEST KITSerono Diagnostics, Inc.·1986-07-16
• K852472 — ABBOTT RSV EIAAbbott Laboratories·1985-09-17
• K852185 — RESPIRATORY SYNCYTIAL VIRUS DIRECT FLUORESCENT ANTBartels Immunodiagnostic Supplies, Inc.·1985-08-19
• K844721 — INNOFLUOR PRIMIDONEInnotron Diagnostics·1985-01-08
• K842047 — ORTHO* RSV ANTIGEN ELISA TEST SYSOrtho Diagnostic Systems, Inc.·1984-10-05
• K841527 — ORTHO RESPIRATORY SYNCYTIAL VIRUS-Ortho Diagnostic Systems, Inc.·1984-08-12
• K831924 — ANTIBODY TO RESPIRATORY SYNCYTIAL VIRUSElectro-Nucleonics Laboratories, Inc.·1983-08-11