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510(k) K870029

Device
IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE
Applicant
AMERICAN MICRO SCAN
510(k) number
K870029
Product code
GWC  
Decision
Substantially Equivalent (SESE)
Decision date
1987-03-25
Date received
1987-01-05
Regulation
866.3740
Classification name
Antisera, All Types, Streptococcus Pneumoniae
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
LORRAINE WEAVER
Address
1584 Enterprise Blvd. West Sacramento CA US 95691 95691

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GWC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K884965BACTIGEN(R) MENINGITIDIS PANELArmkel, LLC1989-02-07
K884966BACTIGEN(R) S. PNEUMONIAEArmkel, LLC1989-02-07
K862848LKB ULTROBACT (TM) PNEUMOCOCCUS KIT; 2321-110Lkb Instruments, Inc.1986-12-18
K842239VENTRESCREEN STREP A TESTVentrex Laboratories, Inc.1984-07-02
K841376WELLCOGEN S. PNEUMONIAEWellcome Diagnostics1984-05-02
K831887BACTIGEN S. PNEUMONIAEArmkel, LLC1983-09-26
K821960BBL PNEUMOSLIDE TESTBd Becton Dickinson Vacutainer Systems Preanalytic1982-07-30
K802337PHADEBACT PNEUMOCOCCUS TESTPharmacia, Inc.1980-10-31

Legacy Summary#

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FDA Review#

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