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FDA 510(k)

BTA STAT TEST PRESCRIPTION HOME USE

K-Number: K974845 · 1998-12-08

ApplicantBard Diagnostic Sciences,Inc.
Decision Date1998-12-08
Product CodeMMW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

BTA STAT TEST PRESCRIPTION HOME USE 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 1998-12-08 under 510(k) number K974845. 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 BTA STAT TEST PRESCRIPTION HOME USE?

BTA STAT TEST PRESCRIPTION HOME USE is a medical device that received FDA 510(k) clearance on 1998-12-08. The listed applicant is Bard Diagnostic Sciences,Inc.. The 510(k) number is K974845.

When did BTA STAT TEST PRESCRIPTION HOME USE receive FDA 510(k) clearance?

BTA STAT TEST PRESCRIPTION HOME USE received FDA 510(k) clearance on 1998-12-08, under 510(k) number K974845.

Who is the listed applicant for BTA STAT TEST PRESCRIPTION HOME USE?

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 BTA STAT TEST PRESCRIPTION HOME USE?

The FDA product code for BTA STAT TEST PRESCRIPTION HOME USE is MMW.

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 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.

K971402BARD BTA TRAK TESTK964151BARD AND BTA 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 KITVysisK971402BARD BTA TRAK TESTBard 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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