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510(k) K852472

Device
Abbott Rsv Eia
Applicant
ABBOTT LABORATORIES
510(k) number
K852472
Product code
LKT
Decision
Substantially Equivalent (SESE)
Decision date
1985-09-17
Date received
1985-06-11
Regulation
866.3480
Classification name
Respiratory Syncytial Virus, Antigen, Antibody, Ifa
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JEAN FRYDMAN
Address
One Abbott Park Rd. Abbott Park IL US 60064 60064

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LKT#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K081928D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KITDiagnostic Hybrids, Inc.2008-12-23
K983336PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1Diagnostic Products Corp.1999-03-18
K943317PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV)Diagnostic Products Corp.1994-12-19
K942173RSV ANTIGEN TESTNeogenex1994-06-30
K912842RSV-MAB TESTGull Laboratories, Inc.1991-12-09
K912838BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNOBaxter Diagnostics, Inc.1991-09-27
K912371BIOMERIEUX RSV DIRECT IF KITVitek Systems, Inc.1991-09-23
K894623RESPIRATORY SYNCYTIAL VIRUSBion Ent., Ltd.1989-10-16
K884192RSV IFA TEST KIT FOR DIRECT ANTIGEN DETECTIONBaxter Diagnostics, Inc.1988-11-22
K882687ANTI-RESPIRATORY SYNCYTIAL VIRUS ANTIBODY TESTGull Laboratories, Inc.1988-08-30
K873564GENETIC SYSTEMS RSV REAGENT CONTROL SLIDESGenetic Systems Corp.1987-11-20
K872701RESPIRATORY SYNCYTIAL VIRUS CF ANTIGEN & CONTROLSita, Inc.1987-09-18
K872082RESPIRATORY SYNCYTIAL VIRUS CONTROL SLIDEMedical Diagnostic Technologies, Inc.1987-07-31
K870176GENETIC SYSTEMS RSV IMMUNOFLUORESCENCE TEST KITGenetic Systems Corp.1987-07-16
K871230ANTIBODY ASSAY FOR DETEC. OF RESP. SYNCYTIAL VIRUSMicroscan Div. Baxter Healthcare Corp.1987-06-26