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FDA 510(k)

HYBRID CAPTURE II CT-ID TEST

K-Number: K990023 · 1999-10-25

ApplicantDigene Corp.
Decision Date1999-10-25
Product CodeLSK
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HYBRID CAPTURE II CT-ID TEST is the device name listed in this FDA 510(k) record. The listed applicant is Digene Corp.. It received FDA 510(k) clearance on 1999-10-25 under 510(k) number K990023. 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 HYBRID CAPTURE II CT-ID TEST?

HYBRID CAPTURE II CT-ID TEST is a medical device that received FDA 510(k) clearance on 1999-10-25. The listed applicant is Digene Corp.. The 510(k) number is K990023.

When did HYBRID CAPTURE II CT-ID TEST receive FDA 510(k) clearance?

HYBRID CAPTURE II CT-ID TEST received FDA 510(k) clearance on 1999-10-25, under 510(k) number K990023.

Who is the listed applicant for HYBRID CAPTURE II CT-ID TEST?

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 HYBRID CAPTURE II CT-ID TEST?

The FDA product code for HYBRID CAPTURE II CT-ID TEST 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.

K010891MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01K010892MODIFICATION 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-IDK974901HYBRID 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.K010891MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01Digene Corp.K010892MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01Digene 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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