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FDA 510(k)

GEN-PROBE APTIMA COMBO 2 ASSAY

K-Number: K022874 · 2002-09-17

ApplicantGen-Probe, Inc.
Decision Date2002-09-17
Product CodeJTW
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GEN-PROBE APTIMA COMBO 2 ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Gen-Probe, Inc.. It received FDA 510(k) clearance on 2002-09-17 under 510(k) number K022874. The device is classified under product code JTW. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEN-PROBE APTIMA COMBO 2 ASSAY?

GEN-PROBE APTIMA COMBO 2 ASSAY is a medical device that received FDA 510(k) clearance on 2002-09-17. The listed applicant is Gen-Probe, Inc.. The 510(k) number is K022874.

When did GEN-PROBE APTIMA COMBO 2 ASSAY receive FDA 510(k) clearance?

GEN-PROBE APTIMA COMBO 2 ASSAY received FDA 510(k) clearance on 2002-09-17, under 510(k) number K022874.

Who is the listed applicant for GEN-PROBE APTIMA COMBO 2 ASSAY?

The FDA 510(k) record lists Gen-Probe, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GEN-PROBE APTIMA COMBO 2 ASSAY?

The FDA product code for GEN-PROBE APTIMA COMBO 2 ASSAY is JTW.

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Other records listing Gen-Probe, Inc. as applicant

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Related Devices (Code: JTW)

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.

K121039COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEMCopan Flock TechnologiesK061301COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEMCopan Diagnostics, Inc.K013819URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEMSierra Diagnostic, LLCK993161COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEMCopan Diagnostics, Inc.K983244SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM)Trek Diagnostic Systems, Inc.K961148CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG)Difco Laboratories, 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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