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FDA 510(k)

HEMODIAL CONCENTRATE

K-Number: K834587 · 1984-04-13

ApplicantMoana Productions, Inc.
Decision Date1984-04-13
Product CodeFKQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HEMODIAL CONCENTRATE is the device name listed in this FDA 510(k) record. The listed applicant is Moana Productions, Inc.. It received FDA 510(k) clearance on 1984-04-13 under 510(k) number K834587. 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 HEMODIAL CONCENTRATE?

HEMODIAL CONCENTRATE is a medical device that received FDA 510(k) clearance on 1984-04-13. The listed applicant is Moana Productions, Inc.. The 510(k) number is K834587.

When did HEMODIAL CONCENTRATE receive FDA 510(k) clearance?

HEMODIAL CONCENTRATE received FDA 510(k) clearance on 1984-04-13, under 510(k) number K834587.

Who is the listed applicant for HEMODIAL CONCENTRATE?

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

What is the FDA product code for HEMODIAL CONCENTRATE?

The FDA product code for HEMODIAL CONCENTRATE is FKQ.

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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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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