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FDA 510(k)

NOVA GEL (TM) SCL-70

K-Number: K880897 · 1988-04-21

ApplicantInova Diagnostics, Inc.
Decision Date1988-04-21
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

NOVA GEL (TM) SCL-70 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 1988-04-21 under 510(k) number K880897. 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 GEL (TM) SCL-70?

NOVA GEL (TM) SCL-70 is a medical device that received FDA 510(k) clearance on 1988-04-21. The listed applicant is Inova Diagnostics, Inc.. The 510(k) number is K880897.

When did NOVA GEL (TM) SCL-70 receive FDA 510(k) clearance?

NOVA GEL (TM) SCL-70 received FDA 510(k) clearance on 1988-04-21, under 510(k) number K880897.

Who is the listed applicant for NOVA GEL (TM) SCL-70?

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 GEL (TM) SCL-70?

The FDA product code for NOVA GEL (TM) SCL-70 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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