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FDA 510(k)

MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01

K-Number: K010891 · 2001-09-25

ApplicantDigene Corp.
Decision Date2001-09-25
Product CodeLSK
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01 is the device name listed in this FDA 510(k) record. The listed applicant is Digene Corp.. It received FDA 510(k) clearance on 2001-09-25 under 510(k) number K010891. The device is classified under product code LSK. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01?

MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01 is a medical device that received FDA 510(k) clearance on 2001-09-25. The listed applicant is Digene Corp.. The 510(k) number is K010891.

When did MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01 receive FDA 510(k) clearance?

MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01 received FDA 510(k) clearance on 2001-09-25, under 510(k) number K010891.

Who is the listed applicant for MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01?

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 II CT/GC TEST, MODEL 03M90-01?

The FDA product code for MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01 is LSK.

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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.

K010892MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01K010893MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01K981567HYBRID 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: LSK)

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.

K092704ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8L07-91, 9K12-03Abbott Molecular, Inc.K010892MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01Digene Corp.K990023HYBRID CAPTURE II CT-ID TESTDigene Corp.K920302PACE 2 CHLAMYDIA TRACHOMATIS PROBE CONFIRM ASSAYGen-Probe, Inc.K920378PACE 2 SYSTEM FOR CHLAMYDIA TRACHOMATISGen-Probe, Inc.K874878GEN-PROBE(R) PACE(TM) SYSTEM CHLAMYDIA TRACHOMATISGen-Probe, 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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