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FDA 510(k)

ACTH RADIOIMMUNOASSAY KIT

K-Number: K811565 · 1981-06-25

ApplicantImmuno Nuclear Corp.
Decision Date1981-06-25
Product CodeCKG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACTH RADIOIMMUNOASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Immuno Nuclear Corp.. It received FDA 510(k) clearance on 1981-06-25 under 510(k) number K811565. 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 RADIOIMMUNOASSAY KIT?

ACTH RADIOIMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1981-06-25. The listed applicant is Immuno Nuclear Corp.. The 510(k) number is K811565.

When did ACTH RADIOIMMUNOASSAY KIT receive FDA 510(k) clearance?

ACTH RADIOIMMUNOASSAY KIT received FDA 510(k) clearance on 1981-06-25, under 510(k) number K811565.

Who is the listed applicant for ACTH RADIOIMMUNOASSAY KIT?

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

What is the FDA product code for ACTH RADIOIMMUNOASSAY KIT?

The FDA product code for ACTH RADIOIMMUNOASSAY KIT is CKG.

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Other records listing Immuno Nuclear 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.

K863743BIOTECH'S IGE IMMUNO RESPONSE TEST ISOTOPE UNITK863973ELM ALLERGEN DISCK863844IMMUNO BIOTECH'S LAMB'S QUARTERS ALLERGEN DISCK863123IMMUNO BIOTECH MUGWART ALLERGEN DISCK863098MEADOW FESCUE ALLERGEN DISCK862266MAPLE ALLERGEN DISC

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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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