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FDA 510(k)

ENA EIA KIT

K-Number: K010147 · 2001-03-01

ApplicantThe Binding Site, Ltd.
Decision Date2001-03-01
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ENA EIA 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 2001-03-01 under 510(k) number K010147. The device is classified under product code LLL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENA EIA KIT?

ENA EIA KIT is a medical device that received FDA 510(k) clearance on 2001-03-01. The listed applicant is The Binding Site, Ltd.. The 510(k) number is K010147.

When did ENA EIA KIT receive FDA 510(k) clearance?

ENA EIA KIT received FDA 510(k) clearance on 2001-03-01, under 510(k) number K010147.

Who is the listed applicant for ENA EIA 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 ENA EIA KIT?

The FDA product code for ENA EIA KIT is LLL.

Other records listing The Binding Site, Ltd. 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.

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Official Source

View on FDA Database →

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

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