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FDA 510(k)

CENTRIFREE MICROPARTITION SYSTEM

K-Number: K820455 · 1982-03-15

ApplicantAmicon, Inc.
Decision Date1982-03-15
Product CodeJRL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CENTRIFREE MICROPARTITION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Amicon, Inc.. It received FDA 510(k) clearance on 1982-03-15 under 510(k) number K820455. The device is classified under product code JRL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CENTRIFREE MICROPARTITION SYSTEM?

CENTRIFREE MICROPARTITION SYSTEM is a medical device that received FDA 510(k) clearance on 1982-03-15. The listed applicant is Amicon, Inc.. The 510(k) number is K820455.

When did CENTRIFREE MICROPARTITION SYSTEM receive FDA 510(k) clearance?

CENTRIFREE MICROPARTITION SYSTEM received FDA 510(k) clearance on 1982-03-15, under 510(k) number K820455.

Who is the listed applicant for CENTRIFREE MICROPARTITION SYSTEM?

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 CENTRIFREE MICROPARTITION SYSTEM?

The FDA product code for CENTRIFREE MICROPARTITION SYSTEM is JRL.

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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: JRL)

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.

K822121ACRO PACKGelman Sciences, Inc.K820224EMIT FREELEVEL SYSTEM ISyva Co.K812750IL 703, STAT SEPARATORInstrumentation Laboratory COK813159VACUSHIELD TMGelman Sciences, Inc.K810829ACRODISCGelman Sciences, Inc.K801500ULTRAFREE CALCIUM FILTERMillipore 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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