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FDA 510(k)

MODEL 795 FLUOROMETER/DENSITOMETER

K-Number: K915332 · 1992-02-18

ApplicantCiba Corning Diagnostics Corp.
Decision Date1992-02-18
Product CodeJQT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODEL 795 FLUOROMETER/DENSITOMETER 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 1992-02-18 under 510(k) number K915332. The device is classified under product code JQT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 795 FLUOROMETER/DENSITOMETER?

MODEL 795 FLUOROMETER/DENSITOMETER is a medical device that received FDA 510(k) clearance on 1992-02-18. The listed applicant is Ciba Corning Diagnostics Corp.. The 510(k) number is K915332.

When did MODEL 795 FLUOROMETER/DENSITOMETER receive FDA 510(k) clearance?

MODEL 795 FLUOROMETER/DENSITOMETER received FDA 510(k) clearance on 1992-02-18, under 510(k) number K915332.

Who is the listed applicant for MODEL 795 FLUOROMETER/DENSITOMETER?

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 MODEL 795 FLUOROMETER/DENSITOMETER?

The FDA product code for MODEL 795 FLUOROMETER/DENSITOMETER is JQT.

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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: JQT)

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.

K111356ASIMANAGER - ATArlington Scientific, Inc.K944185ISOSCANIsolab, Inc.K885254TARGET READERV-Tech, Inc.K860645ELECTROPHORESIS DATA CENTER (EDC)Helena LaboratoriesK862956ICON READERHybritech, Inc.K853734APOLLO DENSITOMETERAstral Medical Systems

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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