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FDA 510(k)

QUANTA LITE M2 EP (MIT3) ELISA

K-Number: K052262 · 2005-10-27

ApplicantInova Diagnostics, Inc.
Decision Date2005-10-27
Product CodeDBM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUANTA LITE M2 EP (MIT3) ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Inova Diagnostics, Inc.. It received FDA 510(k) clearance on 2005-10-27 under 510(k) number K052262. The device is classified under product code DBM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTA LITE M2 EP (MIT3) ELISA?

QUANTA LITE M2 EP (MIT3) ELISA is a medical device that received FDA 510(k) clearance on 2005-10-27. The listed applicant is Inova Diagnostics, Inc.. The 510(k) number is K052262.

When did QUANTA LITE M2 EP (MIT3) ELISA receive FDA 510(k) clearance?

QUANTA LITE M2 EP (MIT3) ELISA received FDA 510(k) clearance on 2005-10-27, under 510(k) number K052262.

Who is the listed applicant for QUANTA LITE M2 EP (MIT3) ELISA?

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

What is the FDA product code for QUANTA LITE M2 EP (MIT3) ELISA?

The FDA product code for QUANTA LITE M2 EP (MIT3) ELISA is DBM.

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Related Devices (Code: DBM)

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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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