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FDA 510(k)

RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIUM TUBER.

K-Number: K871795 · 1987-07-30

ApplicantGen-Probe, Inc.
Decision Date1987-07-30
Product CodeLQF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIUM TUBER. 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 1987-07-30 under 510(k) number K871795. 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 DIAGNOSTIC SYSTEM FOR MYCOBACTERIUM TUBER.?

RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIUM TUBER. is a medical device that received FDA 510(k) clearance on 1987-07-30. The listed applicant is Gen-Probe, Inc.. The 510(k) number is K871795.

When did RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIUM TUBER. receive FDA 510(k) clearance?

RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIUM TUBER. received FDA 510(k) clearance on 1987-07-30, under 510(k) number K871795.

Who is the listed applicant for RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIUM TUBER.?

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 DIAGNOSTIC SYSTEM FOR MYCOBACTERIUM TUBER.?

The FDA product code for RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIUM TUBER. 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.K897077ACCUPROBE MYCOBACTERIUM INTRACELLULARE CULTUREGen-Probe, Inc.K896494ACCUPROBE MYCOBACTERIUM AVIUM CULTURE TESTGen-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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