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FDA 510(k)

ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT

K-Number: K080739 · 2008-07-10

ApplicantAbbott Molecular, Inc.
Decision Date2008-07-10
Product CodeMKZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Molecular, Inc.. It received FDA 510(k) clearance on 2008-07-10 under 510(k) number K080739. The device is classified under product code MKZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT?

ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT is a medical device that received FDA 510(k) clearance on 2008-07-10. The listed applicant is Abbott Molecular, Inc.. The 510(k) number is K080739.

When did ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT receive FDA 510(k) clearance?

ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT received FDA 510(k) clearance on 2008-07-10, under 510(k) number K080739.

Who is the listed applicant for ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT?

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

What is the FDA product code for ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT?

The FDA product code for ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT is MKZ.

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Related Devices (Code: MKZ)

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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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