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FDA 510(k)

SMARTCELL PROCESSING SYSTEM

K-Number: K983022 · 1999-04-02

Decision Date1999-04-02
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SMARTCELL PROCESSING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Harvest Technologies, LLC. It received FDA 510(k) clearance on 1999-04-02 under 510(k) number K983022. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMARTCELL PROCESSING SYSTEM?

SMARTCELL PROCESSING SYSTEM is a medical device that received FDA 510(k) clearance on 1999-04-02. The listed applicant is Harvest Technologies, LLC. The 510(k) number is K983022.

When did SMARTCELL PROCESSING SYSTEM receive FDA 510(k) clearance?

SMARTCELL PROCESSING SYSTEM received FDA 510(k) clearance on 1999-04-02, under 510(k) number K983022.

Who is the listed applicant for SMARTCELL PROCESSING SYSTEM?

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

What is the FDA product code for SMARTCELL PROCESSING SYSTEM?

The FDA product code for SMARTCELL PROCESSING SYSTEM is CAC.

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.

Other records listing Harvest Technologies, LLC 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.

Related Devices (Code: CAC)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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