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FDA 510(k)

ASAHI AM SERIES DIALYZERS

K-Number: K855212 · 1986-01-21

ApplicantAdvocacy International, Ltd.
Decision Date1986-01-21
Product CodeFJI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ASAHI AM SERIES DIALYZERS 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 1986-01-21 under 510(k) number K855212. The device is classified under product code FJI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASAHI AM SERIES DIALYZERS?

ASAHI AM SERIES DIALYZERS is a medical device that received FDA 510(k) clearance on 1986-01-21. The listed applicant is Advocacy International, Ltd.. The 510(k) number is K855212.

When did ASAHI AM SERIES DIALYZERS receive FDA 510(k) clearance?

ASAHI AM SERIES DIALYZERS received FDA 510(k) clearance on 1986-01-21, under 510(k) number K855212.

Who is the listed applicant for ASAHI AM SERIES DIALYZERS?

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 ASAHI AM SERIES DIALYZERS?

The FDA product code for ASAHI AM SERIES DIALYZERS is FJI.

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Other records listing Advocacy International, Ltd. as applicant

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Related Devices (Code: FJI)

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.

K190459Hemoflow F3 and F4 DialyzersFresenius Medical Care Renal Therapies Group, LLCK122952NIPRO PUREFLUX-L HEMODIALYZERNipro Medical CorporationK043342POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LRGambro Renal ProductsK010366DISPOSABLE STORAGE CAPMolded Products, Inc.K011148ULTRACONCENTRATOR SYSTEMInterpore Cross Intl.K002761FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERSFresenius Medical Care North America

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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