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FDA 510(k)

ACTH IRMA KIT II MITSUBISHI YUKA

K-Number: K915727 · 1992-03-02

ApplicantMitsubishi Yuka America, Inc.
Decision Date1992-03-02
Product CodeCKG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACTH IRMA KIT II MITSUBISHI YUKA is the device name listed in this FDA 510(k) record. The listed applicant is Mitsubishi Yuka America, Inc.. It received FDA 510(k) clearance on 1992-03-02 under 510(k) number K915727. The device is classified under product code CKG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACTH IRMA KIT II MITSUBISHI YUKA?

ACTH IRMA KIT II MITSUBISHI YUKA is a medical device that received FDA 510(k) clearance on 1992-03-02. The listed applicant is Mitsubishi Yuka America, Inc.. The 510(k) number is K915727.

When did ACTH IRMA KIT II MITSUBISHI YUKA receive FDA 510(k) clearance?

ACTH IRMA KIT II MITSUBISHI YUKA received FDA 510(k) clearance on 1992-03-02, under 510(k) number K915727.

Who is the listed applicant for ACTH IRMA KIT II MITSUBISHI YUKA?

The FDA 510(k) record lists Mitsubishi Yuka America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACTH IRMA KIT II MITSUBISHI YUKA?

The FDA product code for ACTH IRMA KIT II MITSUBISHI YUKA is CKG.

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Other records listing Mitsubishi Yuka America, Inc. as applicant

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.

K912536CALCITONIN KIT MITSUBISHI YUKA

Related Devices (Code: CKG)

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.

K223867IDS ACTH IIImmunodiagnostic Systems LimitedK111335ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321Tosoh Bioscience, Inc.K060585ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTHRoche Diagnostics Corp.K050748ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011Scantibodies Laboratory, Inc.K021032ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100Scantibodies Laboratory, Inc.K002638FUTURE DIAGNOSTICS B.V. STAT-ACTH KITFuture Diagnostics B.V.

Official Source

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