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FDA 510(k)

DATA MGMT. SYSTEM

K-Number: K842500 · 1984-08-16

ApplicantGilford
Decision Date1984-08-16
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DATA MGMT. SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Gilford. It received FDA 510(k) clearance on 1984-08-16 under 510(k) number K842500. 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 DATA MGMT. SYSTEM?

DATA MGMT. SYSTEM is a medical device that received FDA 510(k) clearance on 1984-08-16. The listed applicant is Gilford. The 510(k) number is K842500.

When did DATA MGMT. SYSTEM receive FDA 510(k) clearance?

DATA MGMT. SYSTEM received FDA 510(k) clearance on 1984-08-16, under 510(k) number K842500.

Who is the listed applicant for DATA MGMT. SYSTEM?

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

What is the FDA product code for DATA MGMT. SYSTEM?

The FDA product code for DATA MGMT. SYSTEM is JJE.

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Other records listing Gilford 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.

K853468GILFORD C4 COMPLEMENT REAGENTK853465GILFORD IMMUNOGLOBULIN G REAGENTK853466GILFORD C3 COMPLEMENT REAGENTK853467GILFORD IMMUNOGLOBULIN A REAGENTK853469GILFORD IMMUNOGLOBULIN M REAGENTK851202GILFORD TRI-LEVEL ASSAYED IMMUNOLOGY CONTROL

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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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