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FDA 510(k)

INPATH E2 COLLECTOR

K-Number: K013258 · 2002-05-31

ApplicantMolecular Diagnostics
Decision Date2002-05-31
Product CodeHHT
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

INPATH E2 COLLECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Molecular Diagnostics. It received FDA 510(k) clearance on 2002-05-31 under 510(k) number K013258. The device is classified under product code HHT. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INPATH E2 COLLECTOR?

INPATH E2 COLLECTOR is a medical device that received FDA 510(k) clearance on 2002-05-31. The listed applicant is Molecular Diagnostics. The 510(k) number is K013258.

When did INPATH E2 COLLECTOR receive FDA 510(k) clearance?

INPATH E2 COLLECTOR received FDA 510(k) clearance on 2002-05-31, under 510(k) number K013258.

Who is the listed applicant for INPATH E2 COLLECTOR?

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

What is the FDA product code for INPATH E2 COLLECTOR?

The FDA product code for INPATH E2 COLLECTOR is HHT.

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Related Devices (Code: HHT)

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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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