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FDA 510(k)

COATEST PLASMINOGEN

K-Number: K854572 · 1986-02-26

ApplicantKabivitrum, Inc.
Decision Date1986-02-26
Product CodeDDX
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

COATEST PLASMINOGEN is the device name listed in this FDA 510(k) record. The listed applicant is Kabivitrum, Inc.. It received FDA 510(k) clearance on 1986-02-26 under 510(k) number K854572. The device is classified under product code DDX. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COATEST PLASMINOGEN?

COATEST PLASMINOGEN is a medical device that received FDA 510(k) clearance on 1986-02-26. The listed applicant is Kabivitrum, Inc.. The 510(k) number is K854572.

When did COATEST PLASMINOGEN receive FDA 510(k) clearance?

COATEST PLASMINOGEN received FDA 510(k) clearance on 1986-02-26, under 510(k) number K854572.

Who is the listed applicant for COATEST PLASMINOGEN?

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

What is the FDA product code for COATEST PLASMINOGEN?

The FDA product code for COATEST PLASMINOGEN is DDX.

Related Clinical Trials

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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Other records listing Kabivitrum, 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.

K884058COATEST PROTEIN CK844664THE I.V. BAGK833890COATEST ANTIPLASMINK833892COATEST FACTOR VIIIK833891COATEST HEPARINK832114COATEST FACTOR X

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Related Devices (Code: DDX)

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.

K941346PLASMINOGEN RID TEST KITThe Binding Site, Ltd.K884766BERICHROM(R) PLASMINOGENBehring Diagnostics, Inc.K864212IL TEST 97573-15, PLASMINOGEN ASSAYInstrumentation Laboratory COK850410GEN. DIAG. CHROMOSTRATE PLASMINOGEN ASSAYWarner-Lambert Co.K832591DIACROM *PLGWellcome DiagnosticsK812625ACA PLASMINOGEN TEST PACKE.I. Dupont DE Nemours & Co., Inc.

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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