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FDA 510(k)

MAGIC MONOCLONAL ANTIBODY TSH(MAB TSH)RADIOIMMUNOA

K-Number: K851329 · 1985-06-13

ApplicantCorning Medical & Scientific
Decision Date1985-06-13
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MAGIC MONOCLONAL ANTIBODY TSH(MAB TSH)RADIOIMMUNOA 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 1985-06-13 under 510(k) number K851329. The device is classified under product code JLW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAGIC MONOCLONAL ANTIBODY TSH(MAB TSH)RADIOIMMUNOA?

MAGIC MONOCLONAL ANTIBODY TSH(MAB TSH)RADIOIMMUNOA is a medical device that received FDA 510(k) clearance on 1985-06-13. The listed applicant is Corning Medical & Scientific. The 510(k) number is K851329.

When did MAGIC MONOCLONAL ANTIBODY TSH(MAB TSH)RADIOIMMUNOA receive FDA 510(k) clearance?

MAGIC MONOCLONAL ANTIBODY TSH(MAB TSH)RADIOIMMUNOA received FDA 510(k) clearance on 1985-06-13, under 510(k) number K851329.

Who is the listed applicant for MAGIC MONOCLONAL ANTIBODY TSH(MAB TSH)RADIOIMMUNOA?

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 MONOCLONAL ANTIBODY TSH(MAB TSH)RADIOIMMUNOA?

The FDA product code for MAGIC MONOCLONAL ANTIBODY TSH(MAB TSH)RADIOIMMUNOA is JLW.

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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: JLW)

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.

K251543Atellica® IM TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc.K243570Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)Siemens Healthcare DiagnosticsK234091Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0Genalyte, Inc.K233050ADVIA Centaur® TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc.K222116Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)Siemens Healthcare Diagnostics, Inc.K221225Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay AnalyzerBeckman Coulter, 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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