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FDA 510(k)

QUANTA LITE TPO ELISA

K-Number: K981857 · 1998-07-29

ApplicantInova Diagnostics, Inc.
Decision Date1998-07-29
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUANTA LITE TPO 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 1998-07-29 under 510(k) number K981857. 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 QUANTA LITE TPO ELISA?

QUANTA LITE TPO ELISA is a medical device that received FDA 510(k) clearance on 1998-07-29. The listed applicant is Inova Diagnostics, Inc.. The 510(k) number is K981857.

When did QUANTA LITE TPO ELISA receive FDA 510(k) clearance?

QUANTA LITE TPO ELISA received FDA 510(k) clearance on 1998-07-29, under 510(k) number K981857.

Who is the listed applicant for QUANTA LITE TPO 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 TPO ELISA?

The FDA product code for QUANTA LITE TPO ELISA is LLL.

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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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