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FDA 510(k)

GEN-PROBE DIRECT GROUP A STREPTOCOCUS TEST

K-Number: K924715 · 1994-03-11

ApplicantGen-Probe, Inc.
Decision Date1994-03-11
Product CodeMDK
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GEN-PROBE DIRECT GROUP A STREPTOCOCUS TEST 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 1994-03-11 under 510(k) number K924715. 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 GEN-PROBE DIRECT GROUP A STREPTOCOCUS TEST?

GEN-PROBE DIRECT GROUP A STREPTOCOCUS TEST is a medical device that received FDA 510(k) clearance on 1994-03-11. The listed applicant is Gen-Probe, Inc.. The 510(k) number is K924715.

When did GEN-PROBE DIRECT GROUP A STREPTOCOCUS TEST receive FDA 510(k) clearance?

GEN-PROBE DIRECT GROUP A STREPTOCOCUS TEST received FDA 510(k) clearance on 1994-03-11, under 510(k) number K924715.

Who is the listed applicant for GEN-PROBE DIRECT GROUP A STREPTOCOCUS TEST?

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 GEN-PROBE DIRECT GROUP A STREPTOCOCUS TEST?

The FDA product code for GEN-PROBE DIRECT GROUP A STREPTOCOCUS TEST 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.K915852ACCUPACE GROUP A STREPTOCOCCUS ID TESTGen-Probe, Inc.K904268ACCUPROBE STREPTOCOCCUS PYOGENES CULTURE CONFIRM.Gen-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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