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FDA 510(k)

PACKETS FOR PREP. OF DIALYSATES & INFUSATES -

K-Number: K851188 · 1985-04-12

ApplicantOrganon Teknika Corp.
Decision Date1985-04-12
Product CodeFKT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PACKETS FOR PREP. OF DIALYSATES & INFUSATES - is the device name listed in this FDA 510(k) record. The listed applicant is Organon Teknika Corp.. It received FDA 510(k) clearance on 1985-04-12 under 510(k) number K851188. The device is classified under product code FKT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PACKETS FOR PREP. OF DIALYSATES & INFUSATES -?

PACKETS FOR PREP. OF DIALYSATES & INFUSATES - is a medical device that received FDA 510(k) clearance on 1985-04-12. The listed applicant is Organon Teknika Corp.. The 510(k) number is K851188.

When did PACKETS FOR PREP. OF DIALYSATES & INFUSATES - receive FDA 510(k) clearance?

PACKETS FOR PREP. OF DIALYSATES & INFUSATES - received FDA 510(k) clearance on 1985-04-12, under 510(k) number K851188.

Who is the listed applicant for PACKETS FOR PREP. OF DIALYSATES & INFUSATES -?

The FDA 510(k) record lists Organon Teknika Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PACKETS FOR PREP. OF DIALYSATES & INFUSATES -?

The FDA product code for PACKETS FOR PREP. OF DIALYSATES & INFUSATES - is FKT.

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Other records listing Organon Teknika Corp. as applicant

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Related Devices (Code: FKT)

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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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