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FDA 510(k)

BIO*NEPHROSS I.Q. ANDANTE

K-Number: K882339 · 1988-06-28

ApplicantOrganon Teknika Corp.
Decision Date1988-06-28
Product CodeFJI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BIO*NEPHROSS I.Q. ANDANTE 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 1988-06-28 under 510(k) number K882339. 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 BIO*NEPHROSS I.Q. ANDANTE?

BIO*NEPHROSS I.Q. ANDANTE is a medical device that received FDA 510(k) clearance on 1988-06-28. The listed applicant is Organon Teknika Corp.. The 510(k) number is K882339.

When did BIO*NEPHROSS I.Q. ANDANTE receive FDA 510(k) clearance?

BIO*NEPHROSS I.Q. ANDANTE received FDA 510(k) clearance on 1988-06-28, under 510(k) number K882339.

Who is the listed applicant for BIO*NEPHROSS I.Q. ANDANTE?

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 BIO*NEPHROSS I.Q. ANDANTE?

The FDA product code for BIO*NEPHROSS I.Q. ANDANTE is FJI.

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Other records listing Organon Teknika Corp. as applicant

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Related Devices (Code: FJI)

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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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