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FDA 510(k)

KDA MICRO CHEMICAL ANALYZER

K-Number: K800572 · 1980-04-02

ApplicantAmerican Monitor Corp.
Decision Date1980-04-02
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

KDA MICRO CHEMICAL ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is American Monitor Corp.. It received FDA 510(k) clearance on 1980-04-02 under 510(k) number K800572. 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 KDA MICRO CHEMICAL ANALYZER?

KDA MICRO CHEMICAL ANALYZER is a medical device that received FDA 510(k) clearance on 1980-04-02. The listed applicant is American Monitor Corp.. The 510(k) number is K800572.

When did KDA MICRO CHEMICAL ANALYZER receive FDA 510(k) clearance?

KDA MICRO CHEMICAL ANALYZER received FDA 510(k) clearance on 1980-04-02, under 510(k) number K800572.

Who is the listed applicant for KDA MICRO CHEMICAL ANALYZER?

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

What is the FDA product code for KDA MICRO CHEMICAL ANALYZER?

The FDA product code for KDA MICRO CHEMICAL ANALYZER is JJE.

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Other records listing American Monitor 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.

K896000ASPARTATE AMINOTRANFERASE (AST)K895999PHOSPHORUSK896001ALANINE AMINOTRANSFERASE (ALT)K895423ACCESS CHEMISTRY ANALYZERK893137EXCEL (TM) CHEMISTRY ANALYZERK892331ENZYMATIC UREA NITROGEN REAGENT SET

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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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