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FDA 510(k)

LAS-R HUMAN PLASMINOGEN TEST

K-Number: K772085 · 1978-01-24

ApplicantHyland Therapeutic Div., Travenol Laboratories
Decision Date1978-01-24
Product CodeDDX
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

LAS-R HUMAN PLASMINOGEN TEST is the device name listed in this FDA 510(k) record. The listed applicant is Hyland Therapeutic Div., Travenol Laboratories. It received FDA 510(k) clearance on 1978-01-24 under 510(k) number K772085. 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 LAS-R HUMAN PLASMINOGEN TEST?

LAS-R HUMAN PLASMINOGEN TEST is a medical device that received FDA 510(k) clearance on 1978-01-24. The listed applicant is Hyland Therapeutic Div., Travenol Laboratories. The 510(k) number is K772085.

When did LAS-R HUMAN PLASMINOGEN TEST receive FDA 510(k) clearance?

LAS-R HUMAN PLASMINOGEN TEST received FDA 510(k) clearance on 1978-01-24, under 510(k) number K772085.

Who is the listed applicant for LAS-R HUMAN PLASMINOGEN TEST?

The FDA 510(k) record lists Hyland Therapeutic Div., Travenol Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LAS-R HUMAN PLASMINOGEN TEST?

The FDA product code for LAS-R HUMAN PLASMINOGEN TEST 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.K864212IL TEST 97573-15, PLASMINOGEN ASSAYInstrumentation Laboratory COK854572COATEST PLASMINOGENKabivitrum, Inc.K850410GEN. DIAG. CHROMOSTRATE PLASMINOGEN ASSAYWarner-Lambert Co.K832591DIACROM *PLGWellcome Diagnostics

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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