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FDA 510(k)

MODEL 654 ANALYZER

K-Number: K921403 · 1992-07-30

ApplicantCiba Corning Diagnostics Corp.
Decision Date1992-07-30
Product CodeJIH
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

MODEL 654 ANALYZER 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 1992-07-30 under 510(k) number K921403. The device is classified under product code JIH. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 654 ANALYZER?

MODEL 654 ANALYZER is a medical device that received FDA 510(k) clearance on 1992-07-30. The listed applicant is Ciba Corning Diagnostics Corp.. The 510(k) number is K921403.

When did MODEL 654 ANALYZER receive FDA 510(k) clearance?

MODEL 654 ANALYZER received FDA 510(k) clearance on 1992-07-30, under 510(k) number K921403.

Who is the listed applicant for MODEL 654 ANALYZER?

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 654 ANALYZER?

The FDA product code for MODEL 654 ANALYZER is JIH.

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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: JIH)

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.

K050338MODIFICATION TO: INSTAREAD LITHIUM SYSTEMAkers Biosciences, Inc.K031579INSTAREAD LITHIUM SYSTEMAkers Laboratories, Inc.K011033DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132Dade Behring, Inc.K934106KODAK EKTACHEM DTSC II SLIDES (LI)Eastman Kodak CompanyK924488KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LI)Eastman Kodak CompanyK895465AMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZEBaxter Healthcare Corp

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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