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FDA 510(k)

CELLTRAK-B

K-Number: K834585 · 1984-05-02

ApplicantR&D Systems, Inc.
Decision Date1984-05-02
Product CodeFRZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CELLTRAK-B 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 1984-05-02 under 510(k) number K834585. The device is classified under product code FRZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CELLTRAK-B?

CELLTRAK-B is a medical device that received FDA 510(k) clearance on 1984-05-02. The listed applicant is R&D Systems, Inc.. The 510(k) number is K834585.

When did CELLTRAK-B receive FDA 510(k) clearance?

CELLTRAK-B received FDA 510(k) clearance on 1984-05-02, under 510(k) number K834585.

Who is the listed applicant for CELLTRAK-B?

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 CELLTRAK-B?

The FDA product code for CELLTRAK-B is FRZ.

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

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Related Devices (Code: FRZ)

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.

K121929ZEPHYR 'X-SERIES PATIENT TRANSFER SLEDDiacor, Inc.K910830INVALIFTAmerican Invalift Corp.K841728LCI MEDICAL INC AIR/PALLehigh Consolidated IndustriesK840796TENDER LIFTING CARELancer Assoc.

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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