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FDA 510(k)

AURA TEK FDP

K-Number: K970353 · 1997-04-30

ApplicantPerimmune, Inc.
Decision Date1997-04-30
Product CodeMMW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AURA TEK FDP is the device name listed in this FDA 510(k) record. The listed applicant is Perimmune, Inc.. It received FDA 510(k) clearance on 1997-04-30 under 510(k) number K970353. The device is classified under product code MMW. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AURA TEK FDP?

AURA TEK FDP is a medical device that received FDA 510(k) clearance on 1997-04-30. The listed applicant is Perimmune, Inc.. The 510(k) number is K970353.

When did AURA TEK FDP receive FDA 510(k) clearance?

AURA TEK FDP received FDA 510(k) clearance on 1997-04-30, under 510(k) number K970353.

Who is the listed applicant for AURA TEK FDP?

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

What is the FDA product code for AURA TEK FDP?

The FDA product code for AURA TEK FDP is MMW.

Other records listing Perimmune, Inc. 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.

K970302APO-TEK LP(A)

Related Devices (Code: MMW)

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.

K203245Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03CNucleix , Ltd.K033982MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TESTVysisK021231NMP22 BLADDERCHEK KIT, NMP22 CONTROL KITMatritech, Inc.K013785UROVYSION BLADDER CANCER RECURRENCE KITVysisK011031VYSIS UROVYSION BLADDER CANCER RECURRENCE KITVysisK974845BTA STAT TEST PRESCRIPTION HOME USEBard Diagnostic Sciences,Inc.

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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