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

Mchenry, IL, US

Erika, Inc. appears in FDA device records in Mchenry, IL. FDA records list 24 510(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
24
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 24 510(k) clearances for Erika, Inc. between 1976 and 1984. The busiest year on record is 1979, with 6. The most recent is 1984, with 3.

Clearances by year, as a table
510(k) clearance decisions for Erika, Inc., by decision year
YearClearances
19762
19773
19796
19801
19813
19824
19832
19843
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K842436ERIKA NEGATIVE PRESS. ARTERIAL BLOODKOCSubstantially Equivalent
K833906NEGATIVE PRESSURE VENOUS BLOOD LINEKOCSubstantially Equivalent
K833905NEGATIVE PRESSURE ARTERIAL BLOODKOCSubstantially Equivalent
K833252ERIKA DI-ALA-KIT-SINGLE DIALYSIS ON/OFKOCSubstantially Equivalent
K830326NEGATIVE PRESSURE ARTERIAL BLOOD LINEKDCSubstantially Equivalent
K822485HPF 100,200,300 CAPILLARY FLOW DIALYZFKQSubstantially Equivalent
K821587ERIKA HPF 50 DIALYZERFJISubstantially Equivalent
K821690ERIKA HPF 100,200,300 DIALYZERFJISubstantially Equivalent
K821304CENTRALYTE BICARBONATE CONCENTRATEKPOSubstantially Equivalent
K812811MICROCOIL 80 DIALYZERFHSSubstantially Equivalent
K811974MICROCOIL 150 DIALYZERFHSSubstantially Equivalent
K810925NATURALYTE BICARBONATE DIALYSATE CONCEN.KPOSubstantially Equivalent
K800723MICRO-COIL 100 COIL DIALYZERFHSSubstantially Equivalent
K792054ERIKA NEGATIVE PRESSURE VENOUS BL SETSFJKSubstantially Equivalent
K792053ERIKA NEGATIVE PRESSURE ARTERILA BLOODFJKSubstantially Equivalent
K791322ERIKA HPF 300FJISubstantially Equivalent
K791321ERIKA HPF 200FJISubstantially Equivalent
K791320ERIKA HPF 100FJISubstantially Equivalent
K781966DIALYZER, MAGNIFLO 100 PARALLEL PLATEFJGSubstantially Equivalent
K771349MODIFICATION TO KIDNEY DIALYZERFHSSubstantially Equivalent
K770171ERIKA I.V. ADMINISTRATION SETFPASubstantially Equivalent
K770382NEEDLE, FISTULA, ERIKAKOCSubstantially Equivalent
K760702ERI-FLO 900 DIALYZERFHSSubstantially Equivalent
K760374DIALYZER (MODEL 1850)FHSSubstantially 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