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FDA 510(k)

ACCUPACE GROUP A STREPTOCOCCUS ID TEST

K-Number: K915852 · 1992-04-02

ApplicantGen-Probe, Inc.
Decision Date1992-04-02
Product CodeMDK
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ACCUPACE GROUP A STREPTOCOCCUS ID 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 1992-04-02 under 510(k) number K915852. 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 ACCUPACE GROUP A STREPTOCOCCUS ID TEST?

ACCUPACE GROUP A STREPTOCOCCUS ID TEST is a medical device that received FDA 510(k) clearance on 1992-04-02. The listed applicant is Gen-Probe, Inc.. The 510(k) number is K915852.

When did ACCUPACE GROUP A STREPTOCOCCUS ID TEST receive FDA 510(k) clearance?

ACCUPACE GROUP A STREPTOCOCCUS ID TEST received FDA 510(k) clearance on 1992-04-02, under 510(k) number K915852.

Who is the listed applicant for ACCUPACE GROUP A STREPTOCOCCUS ID 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 ACCUPACE GROUP A STREPTOCOCCUS ID TEST?

The FDA product code for ACCUPACE GROUP A STREPTOCOCCUS ID TEST is MDK.

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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.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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