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FDA 510(k)

CORNING LACTATE DEHYDROPHORETIC ASSAY

K-Number: K841433 · 1984-05-16

ApplicantCorning Medical & Scientific
Decision Date1984-05-16
Product CodeCFE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CORNING LACTATE DEHYDROPHORETIC ASSAY 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 1984-05-16 under 510(k) number K841433. The device is classified under product code CFE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORNING LACTATE DEHYDROPHORETIC ASSAY?

CORNING LACTATE DEHYDROPHORETIC ASSAY is a medical device that received FDA 510(k) clearance on 1984-05-16. The listed applicant is Corning Medical & Scientific. The 510(k) number is K841433.

When did CORNING LACTATE DEHYDROPHORETIC ASSAY receive FDA 510(k) clearance?

CORNING LACTATE DEHYDROPHORETIC ASSAY received FDA 510(k) clearance on 1984-05-16, under 510(k) number K841433.

Who is the listed applicant for CORNING LACTATE DEHYDROPHORETIC ASSAY?

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 LACTATE DEHYDROPHORETIC ASSAY?

The FDA product code for CORNING LACTATE DEHYDROPHORETIC ASSAY is CFE.

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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: CFE)

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.

K100307GELSCAN, MODEL 1206SebiaK022455SPIFE LD-12 KIT, MODEL 3338Helena LaboratoriesK020467SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452Helena LaboratoriesK970477HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KITSebiaK940224CARDIO REP LDHelena LaboratoriesK921455ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHODE.I. Dupont DE Nemours & Co., 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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