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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

K002024 is an FDA 510(k) premarket notification submitted by Panbio, Inc. for the device "PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA". The FDA issued a decision of Substantially Equivalent on November 22, 2000. The device falls under product code GRY (Antigens, All, Leptospira Spp.), a Class II device regulated under 21 CFR 866.3350. Panbio, Inc. has at least 3 other 510(k) clearances on record.

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)

FDA data resources