CLOTTING FACTOR-VIII-IX-XI-XII DEFICIENT PLASMA— 510(k) K924396

Name: FDA 510(k) clearance K924396
Creator: U.S. Food and Drug Administration
Published: 1993-05-21

Substantially Equivalent

Behring Diagnostics, Inc.

FDA 510(k) clearance K924396 for CLOTTING FACTOR-VIII-IX-XI-XII DEFICIENT PLASMA, Substantially Equivalent on 1993-05-21. Applicant: Behring Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Behring Diagnostics, Inc.
Product code: Code GJT
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 1992-08-31
Decision date: 1993-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerville, NJ, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K924396

K-number listed on FDA's recall record

Z-1713-2015 — Factor deficient plasma for the Siemens BCS¿ / BCS¿ XP System. In vitro diagnostic reagent for the determination of the activity of coagulation factor IX in human plasma by coagulometric methods.Class II·Terminated·Siemens Healthcare Diagnostics, Inc.·20150511

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K924396.

Data sourced from openFDA. This site is unofficial and independent of the FDA.