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FDA 510(k)

AMICON VITAFIBER FLO-PATH BIORECT/VLS CELL CULT SY

K-Number: K892645 · 1989-06-13

ApplicantAmicon, Inc.
Decision Date1989-06-13
Product CodeKJF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

AMICON VITAFIBER FLO-PATH BIORECT/VLS CELL CULT SY is the device name listed in this FDA 510(k) record. The listed applicant is Amicon, Inc.. It received FDA 510(k) clearance on 1989-06-13 under 510(k) number K892645. The device is classified under product code KJF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMICON VITAFIBER FLO-PATH BIORECT/VLS CELL CULT SY?

AMICON VITAFIBER FLO-PATH BIORECT/VLS CELL CULT SY is a medical device that received FDA 510(k) clearance on 1989-06-13. The listed applicant is Amicon, Inc.. The 510(k) number is K892645.

When did AMICON VITAFIBER FLO-PATH BIORECT/VLS CELL CULT SY receive FDA 510(k) clearance?

AMICON VITAFIBER FLO-PATH BIORECT/VLS CELL CULT SY received FDA 510(k) clearance on 1989-06-13, under 510(k) number K892645.

Who is the listed applicant for AMICON VITAFIBER FLO-PATH BIORECT/VLS CELL CULT SY?

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 VITAFIBER FLO-PATH BIORECT/VLS CELL CULT SY?

The FDA product code for AMICON VITAFIBER FLO-PATH BIORECT/VLS CELL CULT SY is KJF.

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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: KJF)

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.

K893787LIFECELL RECOVERY CONTAINERBaxter Healthcare CorpK875221TOOTH PRESERVING SYSTEMBiological Rescue Products, Inc.K780305CELLDynatech Laboratories, Inc.

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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