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FDA 510(k)

EASE-A-CULT

K-Number: K002756 · 2001-02-23

ApplicantDiagnostica, Inc.
Decision Date2001-02-23
Product CodeKHE
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

EASE-A-CULT is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostica, Inc.. It received FDA 510(k) clearance on 2001-02-23 under 510(k) number K002756. 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 EASE-A-CULT?

EASE-A-CULT is a medical device that received FDA 510(k) clearance on 2001-02-23. The listed applicant is Diagnostica, Inc.. The 510(k) number is K002756.

When did EASE-A-CULT receive FDA 510(k) clearance?

EASE-A-CULT received FDA 510(k) clearance on 2001-02-23, under 510(k) number K002756.

Who is the listed applicant for EASE-A-CULT?

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

What is the FDA product code for EASE-A-CULT?

The FDA product code for EASE-A-CULT is KHE.

Other records listing Diagnostica, Inc. as applicant

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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

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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