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510(k) K002024

PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA by Panbio, Inc. — Product Code GRY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2000
Date Received
July 3, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, All, Leptospira Spp.
Device Class
Class II
Regulation Number
866.3350
Review Panel
MI
Submission Type

Other clearances by Panbio, Inc.

  • K970189 — FIF TM (May 21, 1997)
  • K962176 — TPP (October 18, 1996)
  • K910636 — ABS CADKIT (April 29, 1991)

Other clearances for product code GRY

  • K880417 — LEPTOSPIROSIS IHA (April 12, 1988)