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FDA 510(k)

GEN-PROBE MYCOBACTERIUM RAPID CONFIRMATION SYSTEM

K-Number: K860782 · 1986-07-02

ApplicantGen-Probe, Inc.
Decision Date1986-07-02
Product CodeLQF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GEN-PROBE MYCOBACTERIUM RAPID CONFIRMATION SYSTEM 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 1986-07-02 under 510(k) number K860782. The device is classified under product code LQF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEN-PROBE MYCOBACTERIUM RAPID CONFIRMATION SYSTEM?

GEN-PROBE MYCOBACTERIUM RAPID CONFIRMATION SYSTEM is a medical device that received FDA 510(k) clearance on 1986-07-02. The listed applicant is Gen-Probe, Inc.. The 510(k) number is K860782.

When did GEN-PROBE MYCOBACTERIUM RAPID CONFIRMATION SYSTEM receive FDA 510(k) clearance?

GEN-PROBE MYCOBACTERIUM RAPID CONFIRMATION SYSTEM received FDA 510(k) clearance on 1986-07-02, under 510(k) number K860782.

Who is the listed applicant for GEN-PROBE MYCOBACTERIUM RAPID CONFIRMATION SYSTEM?

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 MYCOBACTERIUM RAPID CONFIRMATION SYSTEM?

The FDA product code for GEN-PROBE MYCOBACTERIUM RAPID CONFIRMATION SYSTEM is LQF.

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Other records listing Gen-Probe, Inc. 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.

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Related Devices (Code: LQF)

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.

K921435ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTUREGen-Probe, Inc.K904463ACCUPROBE MYCOBACTERIUM KANSASII CULT CONFIRM TESTGen-Probe, Inc.K896494ACCUPROBE MYCOBACTERIUM AVIUM CULTURE TESTGen-Probe, Inc.K897077ACCUPROBE MYCOBACTERIUM INTRACELLULARE CULTUREGen-Probe, Inc.K897078ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTUREGen-Probe, Inc.K896492ACCUPROBE MYCOBACTERIUM GORDONAE CULTURE TESTGen-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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