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FDA 510(k)

MAGIC TM 125I T3 UPTAKE RADIOASSAY

K-Number: K831613 · 1983-08-11

ApplicantCorning Medical & Scientific
Decision Date1983-08-11
Product CodeKHQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MAGIC TM 125I T3 UPTAKE RADIOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Corning Medical & Scientific. It received FDA 510(k) clearance on 1983-08-11 under 510(k) number K831613. The device is classified under product code KHQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAGIC TM 125I T3 UPTAKE RADIOASSAY?

MAGIC TM 125I T3 UPTAKE RADIOASSAY is a medical device that received FDA 510(k) clearance on 1983-08-11. The listed applicant is Corning Medical & Scientific. The 510(k) number is K831613.

When did MAGIC TM 125I T3 UPTAKE RADIOASSAY receive FDA 510(k) clearance?

MAGIC TM 125I T3 UPTAKE RADIOASSAY received FDA 510(k) clearance on 1983-08-11, under 510(k) number K831613.

Who is the listed applicant for MAGIC TM 125I T3 UPTAKE RADIOASSAY?

The FDA 510(k) record lists Corning Medical & Scientific as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAGIC TM 125I T3 UPTAKE RADIOASSAY?

The FDA product code for MAGIC TM 125I T3 UPTAKE RADIOASSAY is KHQ.

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Other records listing Corning Medical & Scientific 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.

K875122DISPOSABLE STERILE SYRINGE FILTERSK872273CORNING EASY WASH ELISA PLATESK872076CORNING DISPOSABLE ROLLER BOTTLESK863789CORNING ELISA PLATESK854024CORNING MAGIC MAB HCG RADIOIMMUNOASSAYK853634CORNING CELL WELLS-MULTIPLE WELL PLATES

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Related Devices (Code: KHQ)

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.

K981375ACE T UPTAKE REAGENT TU CALIBRATORSSchiapparelli Biosystems, Inc.K980088T-UPTAKE MICROPLATE EIAMonobindK970539CHIRON DIAGNOSTICS ACS:180TU PChiron Diagnostics Corp.K964308VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025)Johnson & Johnson Clinical Diagnostics, Inc.K961488ELECSYS T-UPTAKE ASSAYBoehringer Mannheim Corp.K954807CEDIA T UPTAKE ASSAYBoehringer Mannheim Corp.

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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