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510(k) K002024

Device
PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA
Applicant
PANBIO, INC.
510(k) number
K002024
Product code
GRY  
Decision
Substantially Equivalent (SESE)
Decision date
2000-11-22
Date received
2000-07-03
Regulation
866.3350
Classification name
Antigens, All, Leptospira Spp.
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DAVID C BISHOP
Address
605 Dilworth Rd. Dowingtown PA US 19335 19335

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GRY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K880417LEPTOSPIROSIS IHAHillcrest Biologicals1988-04-12

Legacy Summary#

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FDA Review#

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