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FDA 510(k)

QUANTA PLEX SLE PROFILE 8

K-Number: K040160 · 2004-03-08

ApplicantInova Diagnostics, Inc.
Decision Date2004-03-08
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUANTA PLEX SLE PROFILE 8 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 2004-03-08 under 510(k) number K040160. 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 PLEX SLE PROFILE 8?

QUANTA PLEX SLE PROFILE 8 is a medical device that received FDA 510(k) clearance on 2004-03-08. The listed applicant is Inova Diagnostics, Inc.. The 510(k) number is K040160.

When did QUANTA PLEX SLE PROFILE 8 receive FDA 510(k) clearance?

QUANTA PLEX SLE PROFILE 8 received FDA 510(k) clearance on 2004-03-08, under 510(k) number K040160.

Who is the listed applicant for QUANTA PLEX SLE PROFILE 8?

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 PLEX SLE PROFILE 8?

The FDA product code for QUANTA PLEX SLE PROFILE 8 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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