PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA

Antigens, All, Leptospira Spp.

PANBIO, INC.

The following data is part of a premarket notification filed by Panbio, Inc. with the FDA for Panbio Indx Igm Dip-s-ticks Leptospirosis Test For The Detection Of Igm Antibodies To Leptospira Biflexa.

Pre-market Notification Details

Device IDK002024
510k NumberK002024
Device Name:PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA
ClassificationAntigens, All, Leptospira Spp.
Applicant PANBIO, INC. 605 DILWORTH RD. Downingtown,  PA  19335
ContactDavid C Bishop
CorrespondentDavid C Bishop
PANBIO, INC. 605 DILWORTH RD. Downingtown,  PA  19335
Product CodeGRY  
CFR Regulation Number866.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-07-03
Decision Date2000-11-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613745000169 K002024 000
00613745000152 K002024 000
00613745000046 K002024 000

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