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FDA 510(k)

HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL

K-Number: K113211 · 2012-01-04

ApplicantInstrumentation Laboratory CO
Decision Date2012-01-04
Product CodeGGN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 2012-01-04 under 510(k) number K113211. The device is classified under product code GGN. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL?

HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL is a medical device that received FDA 510(k) clearance on 2012-01-04. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K113211.

When did HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL receive FDA 510(k) clearance?

HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL received FDA 510(k) clearance on 2012-01-04, under 510(k) number K113211.

Who is the listed applicant for HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL?

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

What is the FDA product code for HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL?

The FDA product code for HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL is GGN.

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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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