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FDA 510(k)

INCSTAR ACTH IRMA

K-Number: K940271 · 1994-08-02

ApplicantIncstar Corp.
Decision Date1994-08-02
Product CodeCKG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

INCSTAR ACTH IRMA is the device name listed in this FDA 510(k) record. The listed applicant is Incstar Corp.. It received FDA 510(k) clearance on 1994-08-02 under 510(k) number K940271. 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 INCSTAR ACTH IRMA?

INCSTAR ACTH IRMA is a medical device that received FDA 510(k) clearance on 1994-08-02. The listed applicant is Incstar Corp.. The 510(k) number is K940271.

When did INCSTAR ACTH IRMA receive FDA 510(k) clearance?

INCSTAR ACTH IRMA received FDA 510(k) clearance on 1994-08-02, under 510(k) number K940271.

Who is the listed applicant for INCSTAR ACTH IRMA?

The FDA 510(k) record lists Incstar Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INCSTAR ACTH IRMA?

The FDA product code for INCSTAR ACTH IRMA is CKG.

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Other records listing Incstar Corp. 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.

K963289INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAYK963296INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565)K963297INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560)K960358INCSTAR RUBELLA IGG FAST ELISA ASSAYK960367INCSTAR RUBELLA IGG ELISA ASSAYK960434INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530

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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

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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