Cleared Traditional

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

K002024 · Panbio, Inc. · Microbiology

Nov 2000

Decision

142d

Days

Class 2

Risk

About This 510(k) Submission

K002024 is an FDA 510(k) clearance for the PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA, a Antigens, All, Leptospira Spp. (Class II — Special Controls, product code GRY), submitted by Panbio, Inc. (Dowingtown, US). The FDA issued a Cleared decision on November 22, 2000, 142 days after receiving the submission on July 3, 2000. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3350.

Submission Details

510(k) Number	K002024 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 03, 2000
Decision Date	November 22, 2000
Days to Decision	142 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF