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FDA 510(k)

GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820

K-Number: K974572 · 1998-09-24

ApplicantChugai Pharmaceuticals Co., Ltd.
Decision Date1998-09-24
Product CodeMDK
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820 is the device name listed in this FDA 510(k) record. The listed applicant is Chugai Pharmaceuticals Co., Ltd.. It received FDA 510(k) clearance on 1998-09-24 under 510(k) number K974572. 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 ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820?

GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820 is a medical device that received FDA 510(k) clearance on 1998-09-24. The listed applicant is Chugai Pharmaceuticals Co., Ltd.. The 510(k) number is K974572.

When did GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820 receive FDA 510(k) clearance?

GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820 received FDA 510(k) clearance on 1998-09-24, under 510(k) number K974572.

Who is the listed applicant for GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820?

The FDA 510(k) record lists Chugai Pharmaceuticals Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820?

The FDA product code for GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820 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.

K924715GEN-PROBE DIRECT GROUP A STREPTOCOCUS TESTGen-Probe, Inc.K915852ACCUPACE GROUP A STREPTOCOCCUS ID TESTGen-Probe, Inc.K904268ACCUPROBE STREPTOCOCCUS PYOGENES CULTURE CONFIRM.Gen-Probe, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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