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FDA 510(k)

IL TEST 97573-15, PLASMINOGEN ASSAY

K-Number: K864212 · 1986-12-04

ApplicantInstrumentation Laboratory CO
Decision Date1986-12-04
Product CodeDDX
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IL TEST 97573-15, PLASMINOGEN ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 1986-12-04 under 510(k) number K864212. 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 IL TEST 97573-15, PLASMINOGEN ASSAY?

IL TEST 97573-15, PLASMINOGEN ASSAY is a medical device that received FDA 510(k) clearance on 1986-12-04. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K864212.

When did IL TEST 97573-15, PLASMINOGEN ASSAY receive FDA 510(k) clearance?

IL TEST 97573-15, PLASMINOGEN ASSAY received FDA 510(k) clearance on 1986-12-04, under 510(k) number K864212.

Who is the listed applicant for IL TEST 97573-15, PLASMINOGEN ASSAY?

The FDA 510(k) record lists Instrumentation Laboratory CO as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IL TEST 97573-15, PLASMINOGEN ASSAY?

The FDA product code for IL TEST 97573-15, PLASMINOGEN ASSAY is DDX.

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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.K854572COATEST 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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