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FDA 510(k)

BARD AND BTA TEST

K-Number: K964151 · 1997-04-16

ApplicantBard Diagnostic Sciences,Inc.
Decision Date1997-04-16
Product CodeMMW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

BARD AND BTA TEST is the device name listed in this FDA 510(k) record. The listed applicant is Bard Diagnostic Sciences,Inc.. It received FDA 510(k) clearance on 1997-04-16 under 510(k) number K964151. 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 BARD AND BTA TEST?

BARD AND BTA TEST is a medical device that received FDA 510(k) clearance on 1997-04-16. The listed applicant is Bard Diagnostic Sciences,Inc.. The 510(k) number is K964151.

When did BARD AND BTA TEST receive FDA 510(k) clearance?

BARD AND BTA TEST received FDA 510(k) clearance on 1997-04-16, under 510(k) number K964151.

Who is the listed applicant for BARD AND BTA TEST?

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

What is the FDA product code for BARD AND BTA TEST?

The FDA product code for BARD AND BTA TEST is MMW.

Other records listing Bard Diagnostic Sciences,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.

K974845BTA STAT TEST PRESCRIPTION HOME USEK971402BARD BTA TRAK TEST

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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