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FDA 510(k)

CHEMISTRY ANALYZER

K-Number: K781076 · 1978-08-14

ApplicantJohns Scientific, Inc.
Decision Date1978-08-14
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHEMISTRY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Johns Scientific, Inc.. It received FDA 510(k) clearance on 1978-08-14 under 510(k) number K781076. 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 CHEMISTRY ANALYZER?

CHEMISTRY ANALYZER is a medical device that received FDA 510(k) clearance on 1978-08-14. The listed applicant is Johns Scientific, Inc.. The 510(k) number is K781076.

When did CHEMISTRY ANALYZER receive FDA 510(k) clearance?

CHEMISTRY ANALYZER received FDA 510(k) clearance on 1978-08-14, under 510(k) number K781076.

Who is the listed applicant for CHEMISTRY ANALYZER?

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

What is the FDA product code for CHEMISTRY ANALYZER?

The FDA product code for CHEMISTRY ANALYZER 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 Johns Scientific, 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.

K780083ANALYZER, SELECTIVE, ELECTRONIC

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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