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FDA 510(k)

PATHOPLASMA(R) I & II (PATH CITRATED HUMAN PLASMA)

K-Number: K924401 · 1994-02-22

ApplicantBehring Diagnostics, Inc.
Decision Date1994-02-22
Product CodeGGC
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PATHOPLASMA(R) I & II (PATH CITRATED HUMAN PLASMA) 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 1994-02-22 under 510(k) number K924401. The device is classified under product code GGC. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PATHOPLASMA(R) I & II (PATH CITRATED HUMAN PLASMA)?

PATHOPLASMA(R) I & II (PATH CITRATED HUMAN PLASMA) is a medical device that received FDA 510(k) clearance on 1994-02-22. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K924401.

When did PATHOPLASMA(R) I & II (PATH CITRATED HUMAN PLASMA) receive FDA 510(k) clearance?

PATHOPLASMA(R) I & II (PATH CITRATED HUMAN PLASMA) received FDA 510(k) clearance on 1994-02-22, under 510(k) number K924401.

Who is the listed applicant for PATHOPLASMA(R) I & II (PATH CITRATED HUMAN PLASMA)?

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 PATHOPLASMA(R) I & II (PATH CITRATED HUMAN PLASMA)?

The FDA product code for PATHOPLASMA(R) I & II (PATH CITRATED HUMAN PLASMA) is GGC.

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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.

K973832OPUS HLH CONTROLSK972929N ANTISERUM TO HUMAN ALBUMINK972840N ANTISERUM TO HUMAN TRANSFERRINK973202MODIFICATION OF OPUS FERRITIN TEST SYSTEMK972316OPUS D-DIMERK972116VON WILLEBRAND REAGENT

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Related Devices (Code: GGC)

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.

K102552HEMOSIL LA POSITIVE CONTROLInstrumentation Laboratory COK100103SPECIALTY ASSAYED CONTROL-2Helena LaboratoriesK062306PLASMACON N, PLASMACON L-1, PLASMACON L-2R2 Diagnostics, Inc.K061803STA - CONTROL LA 1+2Diagnostica Stago, Inc.K032804CRYOCHECK WEAK LUPUS POSITIVE CONTROLPrecision BiologicK023312CONTROL PLASMA PDade Behring, 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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