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FDA 510(k)

NATURALYTE BICARBONATE CONCENTRATE-DRY PACK

K-Number: K852310 · 1985-07-26

ApplicantErika, Inc.
Decision Date1985-07-26
Product CodeFKQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NATURALYTE BICARBONATE CONCENTRATE-DRY PACK is the device name listed in this FDA 510(k) record. The listed applicant is Erika, Inc.. It received FDA 510(k) clearance on 1985-07-26 under 510(k) number K852310. The device is classified under product code FKQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NATURALYTE BICARBONATE CONCENTRATE-DRY PACK?

NATURALYTE BICARBONATE CONCENTRATE-DRY PACK is a medical device that received FDA 510(k) clearance on 1985-07-26. The listed applicant is Erika, Inc.. The 510(k) number is K852310.

When did NATURALYTE BICARBONATE CONCENTRATE-DRY PACK receive FDA 510(k) clearance?

NATURALYTE BICARBONATE CONCENTRATE-DRY PACK received FDA 510(k) clearance on 1985-07-26, under 510(k) number K852310.

Who is the listed applicant for NATURALYTE BICARBONATE CONCENTRATE-DRY PACK?

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 NATURALYTE BICARBONATE CONCENTRATE-DRY PACK?

The FDA product code for NATURALYTE BICARBONATE CONCENTRATE-DRY PACK is FKQ.

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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 9714-1K850866TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1LK850865TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1-K850654TORAY INDUS. FILTRYZER HOLLOW FIBER ARTIFICIAL KIDK850655TORAY IND. FILTRYZER HOLLOW FIBER ARTIF. KIDNEY B2

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Related Devices (Code: FKQ)

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.

K052764DIACAP ULTRA DIALYSIS FLUID FILTERB. Braun Medizintechnologie GmbHK893612TWO TANK DISSOLUTION MODULENational Medical Care, Medical Products Div., Inc.K874084MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDMNational Medical Care, Medical Products Div., Inc.K873421KAWASUMI A.V. FISTULA SETKawasumi Laboratories Co., Ltd.K870889ACID FUCHSIN SOLUTIONSD.R.G. Scientific IndustriesK861730ACTRIL FOR KIDNEY MACHINE DISINFECTANTRenal Systems, 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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