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FDA 510(k)

RAPID IDENTI. TEST FOR MYCOBACTERIUM TB COMPLEX

K-Number: K862614 · 1986-11-10

ApplicantGen-Probe, Inc.
Decision Date1986-11-10
Product CodeLQF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RAPID IDENTI. TEST FOR MYCOBACTERIUM TB COMPLEX 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 1986-11-10 under 510(k) number K862614. 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 RAPID IDENTI. TEST FOR MYCOBACTERIUM TB COMPLEX?

RAPID IDENTI. TEST FOR MYCOBACTERIUM TB COMPLEX is a medical device that received FDA 510(k) clearance on 1986-11-10. The listed applicant is Gen-Probe, Inc.. The 510(k) number is K862614.

When did RAPID IDENTI. TEST FOR MYCOBACTERIUM TB COMPLEX receive FDA 510(k) clearance?

RAPID IDENTI. TEST FOR MYCOBACTERIUM TB COMPLEX received FDA 510(k) clearance on 1986-11-10, under 510(k) number K862614.

Who is the listed applicant for RAPID IDENTI. TEST FOR MYCOBACTERIUM TB COMPLEX?

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 RAPID IDENTI. TEST FOR MYCOBACTERIUM TB COMPLEX?

The FDA product code for RAPID IDENTI. TEST FOR MYCOBACTERIUM TB COMPLEX is LQF.

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Other records listing Gen-Probe, Inc. as applicant

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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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