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FDA 510(k)

SORB II

K-Number: K813574 · 1982-03-23

ApplicantOrganon Teknika Corp.
Decision Date1982-03-23
Product CodeFKT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SORB II 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 1982-03-23 under 510(k) number K813574. 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 SORB II?

SORB II is a medical device that received FDA 510(k) clearance on 1982-03-23. The listed applicant is Organon Teknika Corp.. The 510(k) number is K813574.

When did SORB II receive FDA 510(k) clearance?

SORB II received FDA 510(k) clearance on 1982-03-23, under 510(k) number K813574.

Who is the listed applicant for SORB II?

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 SORB II?

The FDA product code for SORB II is FKT.

Other records listing Organon Teknika Corp. as applicant

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Related Devices (Code: FKT)

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

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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