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FDA 510(k)

SPECTROLYSE/FIBRIN

K-Number: K881037 · 1988-07-01

ApplicantCytrx Biopool, Ltd.
Decision Date1988-07-01
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SPECTROLYSE/FIBRIN is the device name listed in this FDA 510(k) record. The listed applicant is Cytrx Biopool, Ltd.. It received FDA 510(k) clearance on 1988-07-01 under 510(k) number K881037. The device is classified under product code GGP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTROLYSE/FIBRIN?

SPECTROLYSE/FIBRIN is a medical device that received FDA 510(k) clearance on 1988-07-01. The listed applicant is Cytrx Biopool, Ltd.. The 510(k) number is K881037.

When did SPECTROLYSE/FIBRIN receive FDA 510(k) clearance?

SPECTROLYSE/FIBRIN received FDA 510(k) clearance on 1988-07-01, under 510(k) number K881037.

Who is the listed applicant for SPECTROLYSE/FIBRIN?

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

What is the FDA product code for SPECTROLYSE/FIBRIN?

The FDA product code for SPECTROLYSE/FIBRIN is GGP.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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