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FDA 510(k)

BERICHROM(R) PLASMINOGEN

K-Number: K884766 · 1989-01-04

ApplicantBehring Diagnostics, Inc.
Decision Date1989-01-04
Product CodeDDX
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

BERICHROM(R) PLASMINOGEN is the device name listed in this FDA 510(k) record. The listed applicant is Behring Diagnostics, Inc.. It received FDA 510(k) clearance on 1989-01-04 under 510(k) number K884766. 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 BERICHROM(R) PLASMINOGEN?

BERICHROM(R) PLASMINOGEN is a medical device that received FDA 510(k) clearance on 1989-01-04. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K884766.

When did BERICHROM(R) PLASMINOGEN receive FDA 510(k) clearance?

BERICHROM(R) PLASMINOGEN received FDA 510(k) clearance on 1989-01-04, under 510(k) number K884766.

Who is the listed applicant for BERICHROM(R) PLASMINOGEN?

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

What is the FDA product code for BERICHROM(R) PLASMINOGEN?

The FDA product code for BERICHROM(R) PLASMINOGEN is DDX.

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Other records listing Behring Diagnostics, 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.

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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.K864212IL TEST 97573-15, PLASMINOGEN ASSAYInstrumentation Laboratory COK854572COATEST PLASMINOGENKabivitrum, Inc.K850410GEN. 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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