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FDA 510(k)

CHEMETRICS ANALYZER II

K-Number: K791296 · 1979-08-03

ApplicantChemetrics Corp.
Decision Date1979-08-03
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHEMETRICS ANALYZER II is the device name listed in this FDA 510(k) record. The listed applicant is Chemetrics Corp.. It received FDA 510(k) clearance on 1979-08-03 under 510(k) number K791296. 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 CHEMETRICS ANALYZER II?

CHEMETRICS ANALYZER II is a medical device that received FDA 510(k) clearance on 1979-08-03. The listed applicant is Chemetrics Corp.. The 510(k) number is K791296.

When did CHEMETRICS ANALYZER II receive FDA 510(k) clearance?

CHEMETRICS ANALYZER II received FDA 510(k) clearance on 1979-08-03, under 510(k) number K791296.

Who is the listed applicant for CHEMETRICS ANALYZER II?

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

What is the FDA product code for CHEMETRICS ANALYZER II?

The FDA product code for CHEMETRICS ANALYZER II is JJE.

Related Clinical Trials

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.

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Other records listing Chemetrics 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.

K770780REAGENTS

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

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