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FDA 510(k)

CORTEX DOUBLE HELIX SAMPLER

K-Number: K800003 · 1980-02-01

ApplicantCortex Research Corp.
Decision Date1980-02-01
Product CodeGLE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CORTEX DOUBLE HELIX SAMPLER is the device name listed in this FDA 510(k) record. The listed applicant is Cortex Research Corp.. It received FDA 510(k) clearance on 1980-02-01 under 510(k) number K800003. The device is classified under product code GLE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORTEX DOUBLE HELIX SAMPLER?

CORTEX DOUBLE HELIX SAMPLER is a medical device that received FDA 510(k) clearance on 1980-02-01. The listed applicant is Cortex Research Corp.. The 510(k) number is K800003.

When did CORTEX DOUBLE HELIX SAMPLER receive FDA 510(k) clearance?

CORTEX DOUBLE HELIX SAMPLER received FDA 510(k) clearance on 1980-02-01, under 510(k) number K800003.

Who is the listed applicant for CORTEX DOUBLE HELIX SAMPLER?

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

What is the FDA product code for CORTEX DOUBLE HELIX SAMPLER?

The FDA product code for CORTEX DOUBLE HELIX SAMPLER is GLE.

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Related Devices (Code: GLE)

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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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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