ClearanceBrief
Panels › Microbiology › Product code LKT · Class 1

Respiratory Syncytial Virus, Antigen, Antibody, Ifa

Regulation 866.3480

0510(k)s in 12 months (23 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
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Top companies in LKT

Decided510(k)Device and applicantCode
Dec 23, 2008K081928D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT
Diagnostic Hybrids, Inc.
LKT
Mar 18, 1999K983336PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1
Diagnostic Products Corp.
LKT
Dec 19, 1994K943317PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV)
Diagnostic Products Corp.
LKT
Jun 30, 1994K942173RSV ANTIGEN TEST
Neogenex
LKT
Dec 9, 1991K912842RSV-MAB TEST
Gull Laboratories, Inc.
LKT
Sep 27, 1991K912838BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNO
Baxter Diagnostics, Inc.
LKT
Sep 23, 1991K912371BIOMERIEUX RSV DIRECT IF KIT
Vitek Systems, Inc.
LKT
Oct 16, 1989K894623RESPIRATORY SYNCYTIAL VIRUS
Bion Ent., Ltd.
LKT
Nov 22, 1988K884192RSV IFA TEST KIT FOR DIRECT ANTIGEN DETECTION
Baxter Diagnostics, Inc.
LKT
Aug 30, 1988K882687ANTI-RESPIRATORY SYNCYTIAL VIRUS ANTIBODY TEST
Gull Laboratories, Inc.
LKT
Nov 20, 1987K873564GENETIC SYSTEMS RSV REAGENT CONTROL SLIDES
Genetic Systems Corp.
LKT
Sep 18, 1987K872701RESPIRATORY SYNCYTIAL VIRUS CF ANTIGEN & CONTROL
Sita, Inc.
LKT
Jul 31, 1987K872082RESPIRATORY SYNCYTIAL VIRUS CONTROL SLIDE
Medical Diagnostic Technologies, Inc.
LKT
Jul 16, 1987K870176GENETIC SYSTEMS RSV IMMUNOFLUORESCENCE TEST KIT
Genetic Systems Corp.
LKT
Jun 26, 1987K871230ANTIBODY ASSAY FOR DETEC. OF RESP. SYNCYTIAL VIRUS
Microscan Div. Baxter Healthcare Corp.
LKT
Aug 21, 1986K862321CELLMATICS RSV DETECTION SYSTEM
Difco Laboratories, Inc.
LKT
Jul 16, 1986K861379MONABRITE RESPIR SYNCYTIAL VIRUS(RSV) TEST KIT
Serono Diagnostics, Inc.
LKT
Sep 17, 1985K852472ABBOTT RSV EIA
Abbott Laboratories
LKT
Aug 19, 1985K852185RESPIRATORY SYNCYTIAL VIRUS DIRECT FLUORESCENT ANT
Bartels Immunodiagnostic Supplies, Inc.
LKT
Jan 8, 1985K844721INNOFLUOR PRIMIDONE
Innotron Diagnostics
LKT
Oct 5, 1984K842047ORTHO* RSV ANTIGEN ELISA TEST SYS
Ortho Diagnostic Systems, Inc.
LKT
Aug 12, 1984K841527ORTHO RESPIRATORY SYNCYTIAL VIRUS-
Ortho Diagnostic Systems, Inc.
LKT
Aug 11, 1983K831924ANTIBODY TO RESPIRATORY SYNCYTIAL VIRUS
Electro-Nucleonics Laboratories, Inc.
LKT

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