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FDA 510(k)

CORNING IMMUNOFIXATION SYS

K-Number: K843614 · 1984-10-05

ApplicantCorning Medical & Scientific
Decision Date1984-10-05
Product CodeCZP
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

CORNING IMMUNOFIXATION SYS 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 1984-10-05 under 510(k) number K843614. The device is classified under product code CZP. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORNING IMMUNOFIXATION SYS?

CORNING IMMUNOFIXATION SYS is a medical device that received FDA 510(k) clearance on 1984-10-05. The listed applicant is Corning Medical & Scientific. The 510(k) number is K843614.

When did CORNING IMMUNOFIXATION SYS receive FDA 510(k) clearance?

CORNING IMMUNOFIXATION SYS received FDA 510(k) clearance on 1984-10-05, under 510(k) number K843614.

Who is the listed applicant for CORNING IMMUNOFIXATION SYS?

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 CORNING IMMUNOFIXATION SYS?

The FDA product code for CORNING IMMUNOFIXATION SYS is CZP.

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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: CZP)

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.

K193525Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin MHORIBA ABX SASK060130IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENTBeckman Coulter, Inc.K040435ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2Roche Diagnostics Corp.K024038N LATEX IGADade Behring, Inc.K993927WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRADWako Chemicals USA, Inc.K983359IGAAbbott Laboratories

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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