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FDA 510(k)

MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01

K-Number: K010893 · 2001-09-24

ApplicantDigene Corp.
Decision Date2001-09-24
Product CodeLSL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01 is the device name listed in this FDA 510(k) record. The listed applicant is Digene Corp.. It received FDA 510(k) clearance on 2001-09-24 under 510(k) number K010893. The device is classified under product code LSL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01?

MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01 is a medical device that received FDA 510(k) clearance on 2001-09-24. The listed applicant is Digene Corp.. The 510(k) number is K010893.

When did MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01 receive FDA 510(k) clearance?

MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01 received FDA 510(k) clearance on 2001-09-24, under 510(k) number K010893.

Who is the listed applicant for MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01?

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

What is the FDA product code for MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01?

The FDA product code for MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01 is LSL.

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Other records listing Digene Corp. 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.

K010891MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01K010892MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01K981567HYBRID CAPTURE II CT/GC TESTK981485HYBRID CAPTURE II GC-IDK990023HYBRID CAPTURE II CT-ID TESTK974901HYBRID CAPTURE SYSTEM CMV DNA ASSAY

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Related Devices (Code: LSL)

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.

K231329Aptima Neisseria gonorrhoeae AssayHologic, Inc.K180681Aptima Combo 2 Assay (Panther System)Hologic, Inc.K173887cobas CT/NG for use on cobas 6800/8800 systemsRoche Molecular Systems, Inc.K173840Xpert CT/NGCepheidK163184cobas® CT/NG v2.0 TestRoche Molecular Systems, Inc.K132270COBAS CT/NG V2.0 TESTRoche Molecular Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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