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FDA 510(k)

HEMOSIL READIPLAS TIN

K-Number: K122584 · 2013-03-24

ApplicantInstrumentation Laboratory CO
Decision Date2013-03-24
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOSIL READIPLAS TIN 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 2013-03-24 under 510(k) number K122584. The device is classified under product code GJS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOSIL READIPLAS TIN?

HEMOSIL READIPLAS TIN is a medical device that received FDA 510(k) clearance on 2013-03-24. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K122584.

When did HEMOSIL READIPLAS TIN receive FDA 510(k) clearance?

HEMOSIL READIPLAS TIN received FDA 510(k) clearance on 2013-03-24, under 510(k) number K122584.

Who is the listed applicant for HEMOSIL READIPLAS TIN?

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 READIPLAS TIN?

The FDA product code for HEMOSIL READIPLAS TIN is GJS.

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Other records listing Instrumentation Laboratory CO as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: GJS)

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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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