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FDA 510(k)

ACCUPROBE STREPTOCOCCUS PYOGENES CULTURE CONFIRM.

K-Number: K904268 · 1990-11-13

ApplicantGen-Probe, Inc.
Decision Date1990-11-13
Product CodeMDK
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ACCUPROBE STREPTOCOCCUS PYOGENES CULTURE CONFIRM. 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 1990-11-13 under 510(k) number K904268. The device is classified under product code MDK. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUPROBE STREPTOCOCCUS PYOGENES CULTURE CONFIRM.?

ACCUPROBE STREPTOCOCCUS PYOGENES CULTURE CONFIRM. is a medical device that received FDA 510(k) clearance on 1990-11-13. The listed applicant is Gen-Probe, Inc.. The 510(k) number is K904268.

When did ACCUPROBE STREPTOCOCCUS PYOGENES CULTURE CONFIRM. receive FDA 510(k) clearance?

ACCUPROBE STREPTOCOCCUS PYOGENES CULTURE CONFIRM. received FDA 510(k) clearance on 1990-11-13, under 510(k) number K904268.

Who is the listed applicant for ACCUPROBE STREPTOCOCCUS PYOGENES CULTURE CONFIRM.?

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 STREPTOCOCCUS PYOGENES CULTURE CONFIRM.?

The FDA product code for ACCUPROBE STREPTOCOCCUS PYOGENES CULTURE CONFIRM. is MDK.

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Other records listing Gen-Probe, Inc. as applicant

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Related Devices (Code: MDK)

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.

K974572GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820Chugai Pharmaceuticals Co., Ltd.K924715GEN-PROBE DIRECT GROUP A STREPTOCOCUS TESTGen-Probe, Inc.K915852ACCUPACE GROUP A STREPTOCOCCUS ID 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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