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FDA 510(k)

GENIE CUP INTEGRATED SCREENING DEVICE

K-Number: K980836 · 1998-06-29

ApplicantApplied Technology Ventures, LLC
Decision Date1998-06-29
Product CodeLDJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

GENIE CUP INTEGRATED SCREENING DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Applied Technology Ventures, LLC. It received FDA 510(k) clearance on 1998-06-29 under 510(k) number K980836. The device is classified under product code LDJ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENIE CUP INTEGRATED SCREENING DEVICE?

GENIE CUP INTEGRATED SCREENING DEVICE is a medical device that received FDA 510(k) clearance on 1998-06-29. The listed applicant is Applied Technology Ventures, LLC. The 510(k) number is K980836.

When did GENIE CUP INTEGRATED SCREENING DEVICE receive FDA 510(k) clearance?

GENIE CUP INTEGRATED SCREENING DEVICE received FDA 510(k) clearance on 1998-06-29, under 510(k) number K980836.

Who is the listed applicant for GENIE CUP INTEGRATED SCREENING DEVICE?

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

What is the FDA product code for GENIE CUP INTEGRATED SCREENING DEVICE?

The FDA product code for GENIE CUP INTEGRATED SCREENING DEVICE is LDJ.

Related Clinical Trials

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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Other records listing Applied Technology Ventures, LLC 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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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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