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FDA 510(k)

AMICON DIAFILTERS 20 & 30 HEMOFILTERS

K-Number: K823288 · 1982-12-16

ApplicantAmicon, Inc.
Decision Date1982-12-16
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AMICON DIAFILTERS 20 & 30 HEMOFILTERS is the device name listed in this FDA 510(k) record. The listed applicant is Amicon, Inc.. It received FDA 510(k) clearance on 1982-12-16 under 510(k) number K823288. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMICON DIAFILTERS 20 & 30 HEMOFILTERS?

AMICON DIAFILTERS 20 & 30 HEMOFILTERS is a medical device that received FDA 510(k) clearance on 1982-12-16. The listed applicant is Amicon, Inc.. The 510(k) number is K823288.

When did AMICON DIAFILTERS 20 & 30 HEMOFILTERS receive FDA 510(k) clearance?

AMICON DIAFILTERS 20 & 30 HEMOFILTERS received FDA 510(k) clearance on 1982-12-16, under 510(k) number K823288.

Who is the listed applicant for AMICON DIAFILTERS 20 & 30 HEMOFILTERS?

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

What is the FDA product code for AMICON DIAFILTERS 20 & 30 HEMOFILTERS?

The FDA product code for AMICON DIAFILTERS 20 & 30 HEMOFILTERS is KDI.

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Other records listing Amicon, Inc. 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.

K930168CENTRICON -50 CONCENTRATORK902837AMICON DIAFILTER 30 HEMOCONCENTRATORK901286AMICON HEMOCONCENTRATOR SETK900280CENTRIPREP 100K895405AMICON MINIFILTER PLUS HEMOFILTERK893733CENTRICON CONCENTRATOR

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Related Devices (Code: KDI)

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.

K261267Careflux H60;Careflux H70;Careflux V500Fresenius Medical Care Renal Therapies Group, LLCK252377NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLCK260533ELISIO™-HNipro Medical CorporationK252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLCK253412Tablo Hemodialysis System (PN-0008000, PN-0006000U)Outset Medical, Inc.K253518FX CorAL 40; FX CorAL 50Fresenius Medical Care Renal Therapies Group, LLC

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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