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FDA 510(k)

HELISAL RAPID BLOOD TEST

K-Number: K953686 · 1996-05-21

ApplicantCortecs, Ltd.
Decision Date1996-05-21
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HELISAL RAPID BLOOD TEST is the device name listed in this FDA 510(k) record. The listed applicant is Cortecs, Ltd.. It received FDA 510(k) clearance on 1996-05-21 under 510(k) number K953686. The device is classified under product code LYR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HELISAL RAPID BLOOD TEST?

HELISAL RAPID BLOOD TEST is a medical device that received FDA 510(k) clearance on 1996-05-21. The listed applicant is Cortecs, Ltd.. The 510(k) number is K953686.

When did HELISAL RAPID BLOOD TEST receive FDA 510(k) clearance?

HELISAL RAPID BLOOD TEST received FDA 510(k) clearance on 1996-05-21, under 510(k) number K953686.

Who is the listed applicant for HELISAL RAPID BLOOD TEST?

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

What is the FDA product code for HELISAL RAPID BLOOD TEST?

The FDA product code for HELISAL RAPID BLOOD TEST is LYR.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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