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FDA 510(k)

LELECTIVE KINETIC SYSTEM-60

K-Number: K780464 · 1978-05-03

ApplicantHycel, Inc.
Decision Date1978-05-03
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LELECTIVE KINETIC SYSTEM-60 is the device name listed in this FDA 510(k) record. The listed applicant is Hycel, Inc.. It received FDA 510(k) clearance on 1978-05-03 under 510(k) number K780464. 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 LELECTIVE KINETIC SYSTEM-60?

LELECTIVE KINETIC SYSTEM-60 is a medical device that received FDA 510(k) clearance on 1978-05-03. The listed applicant is Hycel, Inc.. The 510(k) number is K780464.

When did LELECTIVE KINETIC SYSTEM-60 receive FDA 510(k) clearance?

LELECTIVE KINETIC SYSTEM-60 received FDA 510(k) clearance on 1978-05-03, under 510(k) number K780464.

Who is the listed applicant for LELECTIVE KINETIC SYSTEM-60?

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

What is the FDA product code for LELECTIVE KINETIC SYSTEM-60?

The FDA product code for LELECTIVE KINETIC SYSTEM-60 is JJE.

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Other records listing Hycel, 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.

K802422HYCEL TRIGYCERIDE II TESTK790335HYCEL MK782116KETOSTEROID TEST, HYCEL-17K782176HYCEL LDH-INT TESTK782100HYCEL COUNTER 333K782102HYCEL COUNTER 211

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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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