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FDA 510(k)

CIBA CORNING/SHIMADZU MODEL 580 CLINI. CHEM. ANALY

K-Number: K870833 · 1987-04-01

ApplicantCiba Corning Diagnostics Corp.
Decision Date1987-04-01
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CIBA CORNING/SHIMADZU MODEL 580 CLINI. CHEM. ANALY 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 1987-04-01 under 510(k) number K870833. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CIBA CORNING/SHIMADZU MODEL 580 CLINI. CHEM. ANALY?

CIBA CORNING/SHIMADZU MODEL 580 CLINI. CHEM. ANALY is a medical device that received FDA 510(k) clearance on 1987-04-01. The listed applicant is Ciba Corning Diagnostics Corp.. The 510(k) number is K870833.

When did CIBA CORNING/SHIMADZU MODEL 580 CLINI. CHEM. ANALY receive FDA 510(k) clearance?

CIBA CORNING/SHIMADZU MODEL 580 CLINI. CHEM. ANALY received FDA 510(k) clearance on 1987-04-01, under 510(k) number K870833.

Who is the listed applicant for CIBA CORNING/SHIMADZU MODEL 580 CLINI. CHEM. ANALY?

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 CIBA CORNING/SHIMADZU MODEL 580 CLINI. CHEM. ANALY?

The FDA product code for CIBA CORNING/SHIMADZU MODEL 580 CLINI. CHEM. ANALY is JJE.

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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: JJE)

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.

K183375Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride ElectrodeHoriba, Ltd.K130276DIMENSION EXL WITH LM SYSTEMSiemens Healthcare Diagnostics, Inc.K113253ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K112999DIMENSION CLINICAL CHEMISTRY SYSTEMSiemens Healthcare DiagnosticsK110035INDIKOThermofisher Scientific OYK073370TC MATRIX CLINICAL CHEMISTRY ANALYZERTeco Diagnostics

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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