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FDA 510(k)

ACS CKMB II IMMUNOASSAY

K-Number: K962126 · 1996-06-21

ApplicantCiba Corning Diagnostics Corp.
Decision Date1996-06-21
Product CodeJHS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACS CKMB II IMMUNOASSAY 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 1996-06-21 under 510(k) number K962126. The device is classified under product code JHS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACS CKMB II IMMUNOASSAY?

ACS CKMB II IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1996-06-21. The listed applicant is Ciba Corning Diagnostics Corp.. The 510(k) number is K962126.

When did ACS CKMB II IMMUNOASSAY receive FDA 510(k) clearance?

ACS CKMB II IMMUNOASSAY received FDA 510(k) clearance on 1996-06-21, under 510(k) number K962126.

Who is the listed applicant for ACS CKMB II IMMUNOASSAY?

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 ACS CKMB II IMMUNOASSAY?

The FDA product code for ACS CKMB II IMMUNOASSAY is JHS.

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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 SYSTEMK962041ACS LH2 IMMUNOASSAY

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Related Devices (Code: JHS)

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.

K160570Creatine KinaseRoche Diagnostics Operations (Rdo)K102706CKMB UDR ASSAYSENTINEL CH. SpAK082226S40 CREATINE KINASE (CK)Alfa Wassermann Diagnostic Technologies, Inc.K062128THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYSDade Behring, Inc.K990439CARESIDE CKCareside, Inc.K990434CARESIDE CKMBCareside, 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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