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FDA 510(k)

IQUANTIFY, VERSION 1.0

K-Number: K011196 · 2001-11-08

ApplicantInsightful Corporation
Decision Date2001-11-08
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IQUANTIFY, VERSION 1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Insightful Corporation. It received FDA 510(k) clearance on 2001-11-08 under 510(k) number K011196. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IQUANTIFY, VERSION 1.0?

IQUANTIFY, VERSION 1.0 is a medical device that received FDA 510(k) clearance on 2001-11-08. The listed applicant is Insightful Corporation. The 510(k) number is K011196.

When did IQUANTIFY, VERSION 1.0 receive FDA 510(k) clearance?

IQUANTIFY, VERSION 1.0 received FDA 510(k) clearance on 2001-11-08, under 510(k) number K011196.

Who is the listed applicant for IQUANTIFY, VERSION 1.0?

The FDA 510(k) record lists Insightful Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IQUANTIFY, VERSION 1.0?

The FDA product code for IQUANTIFY, VERSION 1.0 is LLZ.

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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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