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510(k) K802337

Device
Phadebact Pneumococcus Test
Applicant
PHARMACIA, INC.
510(k) number
K802337
Product code
GWC
Decision
Substantially Equivalent (SESE)
Decision date
1980-10-31
Date received
1980-09-26
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#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

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
K870029IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAEAmerican Micro Scan1987-03-25
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