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FDA 510(k)

INSTACCULT

K-Number: K002930 · 2001-01-22

ApplicantMedtek Diagnostics, LLC
Decision Date2001-01-22
Product CodeKHE
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

INSTACCULT is the device name listed in this FDA 510(k) record. The listed applicant is Medtek Diagnostics, LLC. It received FDA 510(k) clearance on 2001-01-22 under 510(k) number K002930. The device is classified under product code KHE. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSTACCULT?

INSTACCULT is a medical device that received FDA 510(k) clearance on 2001-01-22. The listed applicant is Medtek Diagnostics, LLC. The 510(k) number is K002930.

When did INSTACCULT receive FDA 510(k) clearance?

INSTACCULT received FDA 510(k) clearance on 2001-01-22, under 510(k) number K002930.

Who is the listed applicant for INSTACCULT?

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

What is the FDA product code for INSTACCULT?

The FDA product code for INSTACCULT is KHE.

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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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