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FDA 510(k)

NOVA LITE(TM) AUTOANTIBODY CONTROLS

K-Number: K881340 · 1988-06-08

ApplicantInova Diagnostics, Inc.
Decision Date1988-06-08
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

NOVA LITE(TM) AUTOANTIBODY CONTROLS 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 1988-06-08 under 510(k) number K881340. 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 NOVA LITE(TM) AUTOANTIBODY CONTROLS?

NOVA LITE(TM) AUTOANTIBODY CONTROLS is a medical device that received FDA 510(k) clearance on 1988-06-08. The listed applicant is Inova Diagnostics, Inc.. The 510(k) number is K881340.

When did NOVA LITE(TM) AUTOANTIBODY CONTROLS receive FDA 510(k) clearance?

NOVA LITE(TM) AUTOANTIBODY CONTROLS received FDA 510(k) clearance on 1988-06-08, under 510(k) number K881340.

Who is the listed applicant for NOVA LITE(TM) AUTOANTIBODY CONTROLS?

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 NOVA LITE(TM) AUTOANTIBODY CONTROLS?

The FDA product code for NOVA LITE(TM) AUTOANTIBODY CONTROLS is LLL.

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Related Devices (Code: 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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