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FDA 510(k)

MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM

K-Number: K934594 · 1994-04-21

ApplicantCiba Corning Diagnostics Corp.
Decision Date1994-04-21
Product CodeDGC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY 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 1994-04-21 under 510(k) number K934594. The device is classified under product code DGC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM?

MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM is a medical device that received FDA 510(k) clearance on 1994-04-21. The listed applicant is Ciba Corning Diagnostics Corp.. The 510(k) number is K934594.

When did MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM receive FDA 510(k) clearance?

MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM received FDA 510(k) clearance on 1994-04-21, under 510(k) number K934594.

Who is the listed applicant for MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY 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 MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM?

The FDA product code for MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM is DGC.

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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: DGC)

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.

K231151Kenota 1 Total IgE; Kenota 1 (instrument)Kenota, Inc.K214068Quantia IgEBiokit, S.A.K220178Total Immunoglobulin E (IgE)Beckman Coulter, Inc.K193493ADVIA Centaur Total IgE (tIgE)Siemens Healthcare Diagnostics, Inc.K161899ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve ControlsPhadia ABK063425DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGHDade Behring, 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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