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FDA 510(k)

MODEL 203S CLINICAL CHEMISTRY ANALYZER

K-Number: K801889 · 1980-09-26

ApplicantGilford Instrument Laboratories, Inc.
Decision Date1980-09-26
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODEL 203S CLINICAL CHEMISTRY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Gilford Instrument Laboratories, Inc.. It received FDA 510(k) clearance on 1980-09-26 under 510(k) number K801889. 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 MODEL 203S CLINICAL CHEMISTRY ANALYZER?

MODEL 203S CLINICAL CHEMISTRY ANALYZER is a medical device that received FDA 510(k) clearance on 1980-09-26. The listed applicant is Gilford Instrument Laboratories, Inc.. The 510(k) number is K801889.

When did MODEL 203S CLINICAL CHEMISTRY ANALYZER receive FDA 510(k) clearance?

MODEL 203S CLINICAL CHEMISTRY ANALYZER received FDA 510(k) clearance on 1980-09-26, under 510(k) number K801889.

Who is the listed applicant for MODEL 203S CLINICAL CHEMISTRY ANALYZER?

The FDA 510(k) record lists Gilford Instrument Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL 203S CLINICAL CHEMISTRY ANALYZER?

The FDA product code for MODEL 203S CLINICAL CHEMISTRY ANALYZER is JJE.

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Other records listing Gilford Instrument Laboratories, Inc. 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.

K823233SBA 300 CLINICAL CHEMISTRY ANALYZERK821583AMES/GILFORD OPTIMATE CLIN. CHEM & THERK802609CHEMISTRY ANALYZER IMPACT 400K800085SYSTEM 203 CHEMISTRY ANALYZERK792361SYSTEM 103 CHEMISTRY ANALYZERK792087MICROFLAME PHOTOMETER

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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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