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FDA 510(k)

SEPACELL R-500 & SEPACELL R-500A

K-Number: K854259 · 1986-01-08

ApplicantAdvocacy International, Ltd.
Decision Date1986-01-08
Product CodeCAK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SEPACELL R-500 & SEPACELL R-500A is the device name listed in this FDA 510(k) record. The listed applicant is Advocacy International, Ltd.. It received FDA 510(k) clearance on 1986-01-08 under 510(k) number K854259. The device is classified under product code CAK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEPACELL R-500 & SEPACELL R-500A?

SEPACELL R-500 & SEPACELL R-500A is a medical device that received FDA 510(k) clearance on 1986-01-08. The listed applicant is Advocacy International, Ltd.. The 510(k) number is K854259.

When did SEPACELL R-500 & SEPACELL R-500A receive FDA 510(k) clearance?

SEPACELL R-500 & SEPACELL R-500A received FDA 510(k) clearance on 1986-01-08, under 510(k) number K854259.

Who is the listed applicant for SEPACELL R-500 & SEPACELL R-500A?

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

What is the FDA product code for SEPACELL R-500 & SEPACELL R-500A?

The FDA product code for SEPACELL R-500 & SEPACELL R-500A is CAK.

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Other records listing Advocacy International, Ltd. 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.

K874027LIPASE UV [TOYO]K873792SEPACELL R-500 AND SEPACELL R-500AK855251MODIFICATION ASAHI NEW PAN-SERIES HEMOFILTERSK855212ASAHI AM SERIES DIALYZERSK842103TOYO JOZO URIC ACID TESTK842104TOYO JOZO G-GTP TEST

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Related Devices (Code: CAK)

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.

K061103HAEMONETICS 40U RBC FILTER BAGHaemonetics Corp.K022477SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SETSummit Medical , Ltd.K000719NEOCARE 20 MICRON BLOOD FILTERWhatman, Inc.K990310CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER)Charter Medical, Ltd.K982822FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER SET MODEL 4C72Baxter Healthcare CorpK972159FENWAL 40 MICRON TRANSFUSION FILTERBaxter Healthcare Corp

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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