FACTOR DEFICIENT PLASMAS - FACTOR XI (11)— 510(k) K972286

Name: FDA 510(k) clearance K972286
Creator: U.S. Food and Drug Administration
Published: 1997-07-14

Substantially Equivalent

Universal Reagents, Inc.

FDA 510(k) clearance K972286 for FACTOR DEFICIENT PLASMAS - FACTOR XI (11), Substantially Equivalent on 1997-07-14. Applicant: Universal Reagents, Inc.. Device class: 2.

Clearance details

Applicant: Universal Reagents, Inc.
Product code: Code GJT
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 1997-06-19
Decision date: 1997-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GJT

view all

K222831 — CRYOcheck Factor VIII Deficient Plasma with VWF2023-09-13
K180486 — HemosIL Factor XII Deficient Plasma2018-03-22
K102851 — NOFACT VIII2011-12-19
K102908 — NOFACT IX2011-12-19
K110237 — HEMOSIL FACTOR VIII DEFICIENT PLASMA2011-07-08

More clearances from Universal Reagents, Inc.

view all

K973143 — UNIVERSAL REAGENT FACTOR XII (TWELVE) DEFICIENT PLASMA1997-09-25
K972288 — FACTOR DEFICIENT PLASMAS - FACTOR IX (9)1997-07-14
K970593 — UNIVERSAL REAGENT FACTOR VIII DEFICIENT PLASMA1997-04-25
K970607 — UNIVERSAL REAGENT FACTOR VII DEFICIENT PLASMA1997-04-25
K964270 — UNIVERSAL REAGENT FACTOR V DEFICIENT PLASMA1996-12-18

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