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FDA 510(k)

IMPACT 400 #1447X2

K-Number: K833067 · 1983-12-08

ApplicantGilford
Decision Date1983-12-08
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMPACT 400 #1447X2 is the device name listed in this FDA 510(k) record. The listed applicant is Gilford. It received FDA 510(k) clearance on 1983-12-08 under 510(k) number K833067. 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 IMPACT 400 #1447X2?

IMPACT 400 #1447X2 is a medical device that received FDA 510(k) clearance on 1983-12-08. The listed applicant is Gilford. The 510(k) number is K833067.

When did IMPACT 400 #1447X2 receive FDA 510(k) clearance?

IMPACT 400 #1447X2 received FDA 510(k) clearance on 1983-12-08, under 510(k) number K833067.

Who is the listed applicant for IMPACT 400 #1447X2?

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 IMPACT 400 #1447X2?

The FDA product code for IMPACT 400 #1447X2 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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