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FDA 510(k)

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

K-Number: K002024 · 2000-11-22

ApplicantPanbio, Inc.
Decision Date2000-11-22
Product CodeGRY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA is the device name listed in this FDA 510(k) record. The listed applicant is Panbio, Inc.. It received FDA 510(k) clearance on 2000-11-22 under 510(k) number K002024. The device is classified under product code GRY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA is a medical device that received FDA 510(k) clearance on 2000-11-22. The listed applicant is Panbio, Inc.. The 510(k) number is K002024.

When did PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA receive FDA 510(k) clearance?

PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA received FDA 510(k) clearance on 2000-11-22, under 510(k) number K002024.

Who is the listed applicant for PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA?

The FDA 510(k) record lists Panbio, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA?

The FDA product code for PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA is GRY.

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Other records listing Panbio, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K970189FIF TMK962176TPPK910636ABS CADKIT

Related Devices (Code: GRY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K880417LEPTOSPIROSIS IHAHillcrest Biologicals

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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