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FDA 510(k)

IMMO PHASE, THYROID HORMONE

K-Number: K781409 · 1978-09-27

ApplicantCorning Medical & Scientific
Decision Date1978-09-27
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMMO PHASE, THYROID HORMONE 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 1978-09-27 under 510(k) number K781409. 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 IMMO PHASE, THYROID HORMONE?

IMMO PHASE, THYROID HORMONE is a medical device that received FDA 510(k) clearance on 1978-09-27. The listed applicant is Corning Medical & Scientific. The 510(k) number is K781409.

When did IMMO PHASE, THYROID HORMONE receive FDA 510(k) clearance?

IMMO PHASE, THYROID HORMONE received FDA 510(k) clearance on 1978-09-27, under 510(k) number K781409.

Who is the listed applicant for IMMO PHASE, THYROID HORMONE?

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 IMMO PHASE, THYROID HORMONE?

The FDA product code for IMMO PHASE, THYROID HORMONE is JLW.

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Other records listing Corning Medical & Scientific as applicant

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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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