FDA 510(k)

BINDAZYME ANTI-MPO ENZYME IMMUNOASSAY KIT

K-Number: K981030 · 1998-07-20

Decision Date1998-07-20

Product CodeMOB

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

BINDAZYME ANTI-MPO ENZYME IMMUNOASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is The Binding Site, Ltd.. It received FDA 510(k) clearance on 1998-07-20 under 510(k) number K981030. The device is classified under product code MOB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BINDAZYME ANTI-MPO ENZYME IMMUNOASSAY KIT?

BINDAZYME ANTI-MPO ENZYME IMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1998-07-20. The listed applicant is The Binding Site, Ltd.. The 510(k) number is K981030.

When did BINDAZYME ANTI-MPO ENZYME IMMUNOASSAY KIT receive FDA 510(k) clearance?

BINDAZYME ANTI-MPO ENZYME IMMUNOASSAY KIT received FDA 510(k) clearance on 1998-07-20, under 510(k) number K981030.

Who is the listed applicant for BINDAZYME ANTI-MPO ENZYME IMMUNOASSAY KIT?

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

What is the FDA product code for BINDAZYME ANTI-MPO ENZYME IMMUNOASSAY KIT?

The FDA product code for BINDAZYME ANTI-MPO ENZYME IMMUNOASSAY KIT is MOB.

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Other records listing The Binding Site, Ltd. as applicant

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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.