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FDA 510(k)

ALKALINE PHOSPHATASE ISOENZYME SYSTEM

K-Number: K885024 · 1989-02-17

ApplicantCiba Corning Diagnostics Corp.
Decision Date1989-02-17
Product CodeCIN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALKALINE PHOSPHATASE ISOENZYME SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ciba Corning Diagnostics Corp.. It received FDA 510(k) clearance on 1989-02-17 under 510(k) number K885024. 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 PHOSPHATASE ISOENZYME SYSTEM?

ALKALINE PHOSPHATASE ISOENZYME SYSTEM is a medical device that received FDA 510(k) clearance on 1989-02-17. The listed applicant is Ciba Corning Diagnostics Corp.. The 510(k) number is K885024.

When did ALKALINE PHOSPHATASE ISOENZYME SYSTEM receive FDA 510(k) clearance?

ALKALINE PHOSPHATASE ISOENZYME SYSTEM received FDA 510(k) clearance on 1989-02-17, under 510(k) number K885024.

Who is the listed applicant for ALKALINE PHOSPHATASE ISOENZYME SYSTEM?

The FDA 510(k) record lists Ciba Corning Diagnostics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALKALINE PHOSPHATASE ISOENZYME SYSTEM?

The FDA product code for ALKALINE PHOSPHATASE ISOENZYME SYSTEM is CIN.

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Other records listing Ciba Corning Diagnostics Corp. 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.

K962559ACS CORTISOL IMMUNOASSAYK963251CIBA CORNING ACS;180 DPD ASSAYK961807CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4K961657CIBA CORNING 400 SYSTEMK962021CIBA CORNING 348 SYSTEMK962126ACS CKMB II IMMUNOASSAY

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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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