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FDA 510(k)

ALKALINE PHOSPHATES ISOENZYME SUBSTRATE

K-Number: K830118 · 1983-02-25

ApplicantCorning Medical & Scientific
Decision Date1983-02-25
Product CodeCIN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALKALINE PHOSPHATES ISOENZYME SUBSTRATE 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 1983-02-25 under 510(k) number K830118. The device is classified under product code CIN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALKALINE PHOSPHATES ISOENZYME SUBSTRATE?

ALKALINE PHOSPHATES ISOENZYME SUBSTRATE is a medical device that received FDA 510(k) clearance on 1983-02-25. The listed applicant is Corning Medical & Scientific. The 510(k) number is K830118.

When did ALKALINE PHOSPHATES ISOENZYME SUBSTRATE receive FDA 510(k) clearance?

ALKALINE PHOSPHATES ISOENZYME SUBSTRATE received FDA 510(k) clearance on 1983-02-25, under 510(k) number K830118.

Who is the listed applicant for ALKALINE PHOSPHATES ISOENZYME SUBSTRATE?

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 ALKALINE PHOSPHATES ISOENZYME SUBSTRATE?

The FDA product code for ALKALINE PHOSPHATES ISOENZYME SUBSTRATE is CIN.

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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: CIN)

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.

K232904Access OstaseBeckman CoulterK200475IDS-iSYS Ostase BAPImmunodiagnostic Systems , Ltd.K043125ORION DIAGNOSTICA UNIQ PINP RIAOrion Diagnostica, OYK020625SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346Helena LaboratoriesK011113HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132)SebiaK994278ACCESS OSTASE IMMUNOENZYMETRIC ASSAYBeckman 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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