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FDA 510(k)

ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011

K-Number: K050748 · 2005-05-20

ApplicantScantibodies Laboratory, Inc.
Decision Date2005-05-20
Product CodeCKG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011 is the device name listed in this FDA 510(k) record. The listed applicant is Scantibodies Laboratory, Inc.. It received FDA 510(k) clearance on 2005-05-20 under 510(k) number K050748. 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 IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011?

ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011 is a medical device that received FDA 510(k) clearance on 2005-05-20. The listed applicant is Scantibodies Laboratory, Inc.. The 510(k) number is K050748.

When did ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011 receive FDA 510(k) clearance?

ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011 received FDA 510(k) clearance on 2005-05-20, under 510(k) number K050748.

Who is the listed applicant for ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011?

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

What is the FDA product code for ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011?

The FDA product code for ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011 is CKG.

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Other records listing Scantibodies Laboratory, 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.

K060578CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION)K060420MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA) ASSAY KIT, MODEL 3KG002K060348MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KITK051888TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013K051810WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT, MODEL 3KG014K051150TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT

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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.K021032ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100Scantibodies Laboratory, Inc.K002638FUTURE DIAGNOSTICS B.V. STAT-ACTH KITFuture Diagnostics B.V.K982608SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KITSangui Biotech, 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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