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FDA 510(k)

ACCUPROBE GROUP B STREPTOCOCCUS CULTURE CONFIRMA.

K-Number: K894711 · 1989-11-14

ApplicantGen-Probe, Inc.
Decision Date1989-11-14
Product CodeGTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ACCUPROBE GROUP B STREPTOCOCCUS CULTURE CONFIRMA. 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 1989-11-14 under 510(k) number K894711. The device is classified under product code GTZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUPROBE GROUP B STREPTOCOCCUS CULTURE CONFIRMA.?

ACCUPROBE GROUP B STREPTOCOCCUS CULTURE CONFIRMA. is a medical device that received FDA 510(k) clearance on 1989-11-14. The listed applicant is Gen-Probe, Inc.. The 510(k) number is K894711.

When did ACCUPROBE GROUP B STREPTOCOCCUS CULTURE CONFIRMA. receive FDA 510(k) clearance?

ACCUPROBE GROUP B STREPTOCOCCUS CULTURE CONFIRMA. received FDA 510(k) clearance on 1989-11-14, under 510(k) number K894711.

Who is the listed applicant for ACCUPROBE GROUP B STREPTOCOCCUS CULTURE CONFIRMA.?

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 GROUP B STREPTOCOCCUS CULTURE CONFIRMA.?

The FDA product code for ACCUPROBE GROUP B STREPTOCOCCUS CULTURE CONFIRMA. is GTZ.

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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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