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FDA 510(k)

ELISA TEST, SEROLOGY

K-Number: K003794 · 2001-03-30

ApplicantMicro Detect, Inc.
Decision Date2001-03-30
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ELISA TEST, SEROLOGY is the device name listed in this FDA 510(k) record. The listed applicant is Micro Detect, Inc.. It received FDA 510(k) clearance on 2001-03-30 under 510(k) number K003794. The device is classified under product code LYR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELISA TEST, SEROLOGY?

ELISA TEST, SEROLOGY is a medical device that received FDA 510(k) clearance on 2001-03-30. The listed applicant is Micro Detect, Inc.. The 510(k) number is K003794.

When did ELISA TEST, SEROLOGY receive FDA 510(k) clearance?

ELISA TEST, SEROLOGY received FDA 510(k) clearance on 2001-03-30, under 510(k) number K003794.

Who is the listed applicant for ELISA TEST, SEROLOGY?

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

What is the FDA product code for ELISA TEST, SEROLOGY?

The FDA product code for ELISA TEST, SEROLOGY is LYR.

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Other records listing Micro Detect, Inc. as applicant

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Related Devices (Code: LYR)

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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