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FDA 510(k)

GLYCACOR

K-Number: K980888 · 1998-08-13

ApplicantExocell, Inc.
Decision Date1998-08-13
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GLYCACOR is the device name listed in this FDA 510(k) record. The listed applicant is Exocell, Inc.. It received FDA 510(k) clearance on 1998-08-13 under 510(k) number K980888. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLYCACOR?

GLYCACOR is a medical device that received FDA 510(k) clearance on 1998-08-13. The listed applicant is Exocell, Inc.. The 510(k) number is K980888.

When did GLYCACOR receive FDA 510(k) clearance?

GLYCACOR received FDA 510(k) clearance on 1998-08-13, under 510(k) number K980888.

Who is the listed applicant for GLYCACOR?

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

What is the FDA product code for GLYCACOR?

The FDA product code for GLYCACOR is LCP.

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Other records listing Exocell, Inc. as applicant

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.

K894423ACC.U.DIALK893453GLYCABENK891544DIALBUMINK884146ALBUWELL

Related Devices (Code: LCP)

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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