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FDA 510(k)

COAGULATION FACTOR DEFICIENT PLASMA

K-Number: K840114 · 1984-02-04

ApplicantMedical Specialties Laboratories
Decision Date1984-02-04
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COAGULATION FACTOR DEFICIENT PLASMA is the device name listed in this FDA 510(k) record. The listed applicant is Medical Specialties Laboratories. It received FDA 510(k) clearance on 1984-02-04 under 510(k) number K840114. 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 COAGULATION FACTOR DEFICIENT PLASMA?

COAGULATION FACTOR DEFICIENT PLASMA is a medical device that received FDA 510(k) clearance on 1984-02-04. The listed applicant is Medical Specialties Laboratories. The 510(k) number is K840114.

When did COAGULATION FACTOR DEFICIENT PLASMA receive FDA 510(k) clearance?

COAGULATION FACTOR DEFICIENT PLASMA received FDA 510(k) clearance on 1984-02-04, under 510(k) number K840114.

Who is the listed applicant for COAGULATION FACTOR DEFICIENT PLASMA?

The FDA 510(k) record lists Medical Specialties Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COAGULATION FACTOR DEFICIENT PLASMA?

The FDA product code for COAGULATION FACTOR DEFICIENT PLASMA is GGP.

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Other records listing Medical Specialties Laboratories 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.

K852643UNI-PLATEK844897HEMATOLOGY CONTROL UNI-CELL 5, UNI-CELL 7 & 8K823587UNI-CELLK810268NORMLCERA

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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