PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA— 510(k) K002024

Name: FDA 510(k) clearance K002024
Creator: U.S. Food and Drug Administration
Published: 2000-11-22

Substantially Equivalent

Panbio, Inc.

FDA 510(k) clearance K002024 for PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA, Substantially Equivalent on 2000-11-22. Applicant: Panbio, Inc.. Device class: 2.

Clearance details

Applicant: Panbio, Inc.
Product code: Code GRY
Device class: Class 2
Regulation: 21 CFR 866.3350
Advisory panel: Microbiology
Date received: 2000-07-03
Decision date: 2000-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dowingtown, PA, US

Download summary PDF View on FDA.gov ↗

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