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FDA 510(k)

REDY 2000

K-Number: K882428 · 1988-10-25

ApplicantOrganon Teknika Corp.
Decision Date1988-10-25
Product CodeFKT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

REDY 2000 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 1988-10-25 under 510(k) number K882428. 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 REDY 2000?

REDY 2000 is a medical device that received FDA 510(k) clearance on 1988-10-25. The listed applicant is Organon Teknika Corp.. The 510(k) number is K882428.

When did REDY 2000 receive FDA 510(k) clearance?

REDY 2000 received FDA 510(k) clearance on 1988-10-25, under 510(k) number K882428.

Who is the listed applicant for REDY 2000?

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 REDY 2000?

The FDA product code for REDY 2000 is FKT.

Other records listing Organon Teknika Corp. as applicant

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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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