FDA 510(k)

BINDAZYME ANTI-TISSUE TRANSGLUTAMINASE IGA EIA

K-Number: K993612 · 1999-12-21

Decision Date1999-12-21

Product CodeMVM

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

BINDAZYME ANTI-TISSUE TRANSGLUTAMINASE IGA EIA 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 1999-12-21 under 510(k) number K993612. The device is classified under product code MVM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BINDAZYME ANTI-TISSUE TRANSGLUTAMINASE IGA EIA?

BINDAZYME ANTI-TISSUE TRANSGLUTAMINASE IGA EIA is a medical device that received FDA 510(k) clearance on 1999-12-21. The listed applicant is The Binding Site, Ltd.. The 510(k) number is K993612.

When did BINDAZYME ANTI-TISSUE TRANSGLUTAMINASE IGA EIA receive FDA 510(k) clearance?

BINDAZYME ANTI-TISSUE TRANSGLUTAMINASE IGA EIA received FDA 510(k) clearance on 1999-12-21, under 510(k) number K993612.

Who is the listed applicant for BINDAZYME ANTI-TISSUE TRANSGLUTAMINASE IGA EIA?

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-TISSUE TRANSGLUTAMINASE IGA EIA?

The FDA product code for BINDAZYME ANTI-TISSUE TRANSGLUTAMINASE IGA EIA is MVM.

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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.