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FDA 510(k)

IL TEST 84668-15, FACTOR VIII CONTROL PLASMA

K-Number: K864480 · 1987-01-21

ApplicantInstrumentation Laboratory CO
Decision Date1987-01-21
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

IL TEST 84668-15, FACTOR VIII CONTROL PLASMA 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 1987-01-21 under 510(k) number K864480. 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 IL TEST 84668-15, FACTOR VIII CONTROL PLASMA?

IL TEST 84668-15, FACTOR VIII CONTROL PLASMA is a medical device that received FDA 510(k) clearance on 1987-01-21. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K864480.

When did IL TEST 84668-15, FACTOR VIII CONTROL PLASMA receive FDA 510(k) clearance?

IL TEST 84668-15, FACTOR VIII CONTROL PLASMA received FDA 510(k) clearance on 1987-01-21, under 510(k) number K864480.

Who is the listed applicant for IL TEST 84668-15, FACTOR VIII CONTROL PLASMA?

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 84668-15, FACTOR VIII CONTROL PLASMA?

The FDA product code for IL TEST 84668-15, FACTOR VIII CONTROL PLASMA is GGP.

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Other records listing Instrumentation Laboratory CO 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: GGP)

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.

K251440CRYOcheck Chromogenic Factor VIIIPrecision Biologic, Inc.K230852HemosIL Chromogenic Factor IXInstrumentation Laboratory CompanyK220728vWF AgSiemens Healthcare Diagnostics Products GmbHK214002CRYOcheck Chromogenic Factor IXPrecision Biologic, Inc.K223402HemosIL von Willebrand Factor AntigenInstrumentation Laboratory COK200033HemosIL von Willebrand Factor AntigenInstrumentation Laboratory CO

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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