510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Amicon, Inc.

Mchenry, IL, US

Amicon, Inc. appears in FDA device records in Mchenry, IL. FDA records list 20 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
20
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 20 510(k) clearances for Amicon, Inc. between 1976 and 1993. The busiest year on record is 1990, with 4. The most recent is 1993, with 1.

Clearances by year, as a table
510(k) clearance decisions for Amicon, Inc., by decision year
YearClearances
19762
19771
19811
19823
19831
19841
19851
19861
19871
19881
19892
19904
19931
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K930168CENTRICON -50 CONCENTRATORJJHSubstantially Equivalent
K902837AMICON DIAFILTER 30 HEMOCONCENTRATORKDISubstantially Equivalent
K901286AMICON HEMOCONCENTRATOR SETKDISubstantially Equivalent
K900280CENTRIPREP 100JJPSubstantially Equivalent
K895405AMICON MINIFILTER PLUS HEMOFILTERKDISubstantially Equivalent
K893733CENTRICON CONCENTRATORJJHSubstantially Equivalent
K892645AMICON VITAFIBER FLO-PATH BIORECT/VLS CELL CULT SYKJFSubstantially Equivalent
K875121AMICON EQUALINE FLUID BALANCE SYSTEMKPFSubstantially Equivalent
K870690CENTRIPREP CONCENTRATORJJHSubstantially Equivalent
K863823AMICON DIAFILTER HEMOFILTERKDISubstantially Equivalent
K853510MINIFILTER HEMOFILTERKDISubstantially Equivalent
K833919CENTRICON MICRO-CONCENTRATORJJHSubstantially Equivalent
K823881ARTERIOVENOUS BLOOD TUBING SET FORKDISubstantially Equivalent
K823288AMICON DIAFILTERS 20 & 30 HEMOFILTERSKDISubstantially Equivalent
K813591HEMOFILTERSKDISubstantially Equivalent
K820455CENTRIFREE MICROPARTITION SYSTEMJRLSubstantially Equivalent
K810810AMICON ULTRAFILTRATION MEMBRANES CMIIDHXSubstantially Equivalent
K770398MINICONJJHSubstantially Equivalent
K761100MULTI-CELL ULTRAFILTRATION SYSTEMJQQSubstantially Equivalent
K760592MINICON CONCENTRATORJJHSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain