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FDA 510(k)

CIBA CORNING ACS:180 AUTO CHEMILUMIN SYST, MODIF

K-Number: K940810 · 1994-05-23

ApplicantCiba Corning Diagnostics Corp.
Decision Date1994-05-23
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CIBA CORNING ACS:180 AUTO CHEMILUMIN SYST, MODIF 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 1994-05-23 under 510(k) number K940810. 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 ACS:180 AUTO CHEMILUMIN SYST, MODIF?

CIBA CORNING ACS:180 AUTO CHEMILUMIN SYST, MODIF is a medical device that received FDA 510(k) clearance on 1994-05-23. The listed applicant is Ciba Corning Diagnostics Corp.. The 510(k) number is K940810.

When did CIBA CORNING ACS:180 AUTO CHEMILUMIN SYST, MODIF receive FDA 510(k) clearance?

CIBA CORNING ACS:180 AUTO CHEMILUMIN SYST, MODIF received FDA 510(k) clearance on 1994-05-23, under 510(k) number K940810.

Who is the listed applicant for CIBA CORNING ACS:180 AUTO CHEMILUMIN SYST, MODIF?

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 ACS:180 AUTO CHEMILUMIN SYST, MODIF?

The FDA product code for CIBA CORNING ACS:180 AUTO CHEMILUMIN SYST, MODIF 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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