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510(k) K811570

Device
ANTIBODY TO CHLAMYDIA TRACHOMATIS
Applicant
ELECTRO-NUCLEONICS LABORATORIES, INC.
510(k) number
K811570
Product code
GPW  
Decision
Substantially Equivalent (SESE)
Decision date
1981-07-23
Date received
1981-06-04
Regulation
866.3120
Classification name
Antigen, Cf, Psittacosis (chlamydia Group)
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GPW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K872700YHLAMYDIA CF ANTIGEN AND CONTROL ANTIGENSita, Inc.1987-10-15
K843654CHLAMYDIAInstitute Virion , Ltd.1985-08-08
K844868CHLAMYDIA GROUP CF ANTIGENHillcrest Biologicals1985-03-05

Legacy Summary#

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FDA Review#

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