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FDA 510(k)

ACCUPROBE MYCOBACTERIUM INTRACELLULARE CULTURE

K-Number: K897077 · 1990-08-23

ApplicantGen-Probe, Inc.
Decision Date1990-08-23
Product CodeLQF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ACCUPROBE MYCOBACTERIUM INTRACELLULARE CULTURE 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 1990-08-23 under 510(k) number K897077. 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 ACCUPROBE MYCOBACTERIUM INTRACELLULARE CULTURE?

ACCUPROBE MYCOBACTERIUM INTRACELLULARE CULTURE is a medical device that received FDA 510(k) clearance on 1990-08-23. The listed applicant is Gen-Probe, Inc.. The 510(k) number is K897077.

When did ACCUPROBE MYCOBACTERIUM INTRACELLULARE CULTURE receive FDA 510(k) clearance?

ACCUPROBE MYCOBACTERIUM INTRACELLULARE CULTURE received FDA 510(k) clearance on 1990-08-23, under 510(k) number K897077.

Who is the listed applicant for ACCUPROBE MYCOBACTERIUM INTRACELLULARE CULTURE?

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 ACCUPROBE MYCOBACTERIUM INTRACELLULARE CULTURE?

The FDA product code for ACCUPROBE MYCOBACTERIUM INTRACELLULARE CULTURE 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.

K122062APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHERK111409APTIMA COMBO 2 ASSAYK063664GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091K063451GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199K062440GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091K061413APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM

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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.K897078ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTUREGen-Probe, Inc.K896492ACCUPROBE MYCOBACTERIUM GORDONAE CULTURE TESTGen-Probe, Inc.K896493ACCUPROBE MYCOBACTERIUM TUBERCULOSIS COMPLEX 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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