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FDA 510(k)

ERIKA HPF 50 DIALYZER

K-Number: K821587 · 1982-06-25

ApplicantErika, Inc.
Decision Date1982-06-25
Product CodeFJI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ERIKA HPF 50 DIALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Erika, Inc.. It received FDA 510(k) clearance on 1982-06-25 under 510(k) number K821587. The device is classified under product code FJI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ERIKA HPF 50 DIALYZER?

ERIKA HPF 50 DIALYZER is a medical device that received FDA 510(k) clearance on 1982-06-25. The listed applicant is Erika, Inc.. The 510(k) number is K821587.

When did ERIKA HPF 50 DIALYZER receive FDA 510(k) clearance?

ERIKA HPF 50 DIALYZER received FDA 510(k) clearance on 1982-06-25, under 510(k) number K821587.

Who is the listed applicant for ERIKA HPF 50 DIALYZER?

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

What is the FDA product code for ERIKA HPF 50 DIALYZER?

The FDA product code for ERIKA HPF 50 DIALYZER is FJI.

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Other records listing Erika, 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.

K853134NATIONAL MED CARE INFUSION PUMP ADM SET #95-0001-8K852309ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1K852310NATURALYTE BICARBONATE CONCENTRATE-DRY PACKK850865TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1-K850866TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1LK850654TORAY INDUS. FILTRYZER HOLLOW FIBER ARTIFICIAL KID

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Related Devices (Code: FJI)

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.

K190459Hemoflow F3 and F4 DialyzersFresenius Medical Care Renal Therapies Group, LLCK122952NIPRO PUREFLUX-L HEMODIALYZERNipro Medical CorporationK043342POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LRGambro Renal ProductsK010366DISPOSABLE STORAGE CAPMolded Products, Inc.K011148ULTRACONCENTRATOR SYSTEMInterpore Cross Intl.K002761FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERSFresenius Medical Care North America

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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