510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K002024Substantially Equivalent

Panbio Indx Igm Dip-S-Ticks Leptospirosis Test for the Detection of Igm Antibodies to Leptospira Biflexa

Panbio Limited, Dowingtown PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K002024 is the FDA 510(k) clearance record for PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA, a class II device, cleared for Panbio, Inc. on under FDA product code GRY (Antigens, All, Leptospira Spp.). FDA records list 8 510(k) clearances for Panbio, Inc., from to . As of , FDA records show no recalls naming K002024.

Clearance record

Decision date
Received
(142 days to decision)
Product code
GRY Antigens, All, Leptospira Spp.
Regulation
21 CFR 866.3350
Device class
Class II
Review panel
Microbiology
Applicant
Panbio, Inc. 605 Dilworth Rd., Dowingtown PA
510(k) summary
Summary
Third party review
No

Clearances, product code GRY

Trailing 12 months

FDA records hold no clearances under product code GRY in the trailing twelve months.

FDA records show no clearances under product code GRY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GRY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260