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FDA 510(k)

HYCEL DILUTOR, VARIOUS MODELS/MULTI

K-Number: K842747 · 1984-10-01

ApplicantR&D Systems, Inc.
Decision Date1984-10-01
Product CodeGKH
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HYCEL DILUTOR, VARIOUS MODELS/MULTI is the device name listed in this FDA 510(k) record. The listed applicant is R&D Systems, Inc.. It received FDA 510(k) clearance on 1984-10-01 under 510(k) number K842747. The device is classified under product code GKH. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYCEL DILUTOR, VARIOUS MODELS/MULTI?

HYCEL DILUTOR, VARIOUS MODELS/MULTI is a medical device that received FDA 510(k) clearance on 1984-10-01. The listed applicant is R&D Systems, Inc.. The 510(k) number is K842747.

When did HYCEL DILUTOR, VARIOUS MODELS/MULTI receive FDA 510(k) clearance?

HYCEL DILUTOR, VARIOUS MODELS/MULTI received FDA 510(k) clearance on 1984-10-01, under 510(k) number K842747.

Who is the listed applicant for HYCEL DILUTOR, VARIOUS MODELS/MULTI?

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

What is the FDA product code for HYCEL DILUTOR, VARIOUS MODELS/MULTI?

The FDA product code for HYCEL DILUTOR, VARIOUS MODELS/MULTI is GKH.

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Other records listing R&D Systems, Inc. as applicant

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Related Devices (Code: GKH)

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.

K100684CELLTRACKS AUTOPREP SYSTEM MODEL:9541Veridex, LLCK040077IMMUNICON CELLTRACKS AUTOPREP SYSTEMImmunicon Corp.K022512CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518Immunicon Corp.K021150COULTER CELLPREPBeckman Coulter, Inc.K935953COULTER MULTI Q PREPCoulter Corp.K923530COULTER MULTI-Q-PREPCoulter Electronics, Inc.

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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