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FDA 510(k)

ACTH IRMA KIT MITSUBISHI YUKA

K-Number: K910178 · 1991-05-22

ApplicantScience Regulatory Services Intl.
Decision Date1991-05-22
Product CodeCKG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACTH IRMA KIT MITSUBISHI YUKA is the device name listed in this FDA 510(k) record. The listed applicant is Science Regulatory Services Intl.. It received FDA 510(k) clearance on 1991-05-22 under 510(k) number K910178. 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 MITSUBISHI YUKA?

ACTH IRMA KIT MITSUBISHI YUKA is a medical device that received FDA 510(k) clearance on 1991-05-22. The listed applicant is Science Regulatory Services Intl.. The 510(k) number is K910178.

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

ACTH IRMA KIT MITSUBISHI YUKA received FDA 510(k) clearance on 1991-05-22, under 510(k) number K910178.

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

The FDA 510(k) record lists Science Regulatory Services Intl. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Clinical Trials

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.

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Other records listing Science Regulatory Services Intl. 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.

K895137DIOTHERM

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

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