Blood Fluid Filters

FDA 510(k) K792723 · Dade, Baxter Travenol Diagnostics, Inc.

Substantially Equivalent

510(k) numberK792723

Submission

Device name
Blood Fluid Filters
Applicant
Dade, Baxter Travenol Diagnostics, Inc.
Mchenry, IL, US
Received
December 31, 1979
Decision date
January 21, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JKA – Tubes, Vials, Systems, Serum Separators, Blood Collection
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1675
Specialty
Clinical Chemistry

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More from Sol-Millennium Medical, Inc.

510(k)DeviceDecision
K800296Whole Blood Gas Control, Levels 1,2,&3GGM · Traditional 03/05/1980SE
K792606Whole Blood Platelet Control Normal,JPK · Traditional 02/13/1980SE
K792607T3 Uptake (T3U) ReagentsKHQ · Traditional 01/16/1980SE
K792443TSH RadioimmunoassayJLW · Traditional 12/27/1979SE
K792442Ferritin RadioimmunoassayDBF · Traditional 12/18/1979SE
K791922Harleco Brand Clinicard Lipase Test SetCET · Traditional 11/27/1979SE
K792183Dade High Density Lipoprotein CholesteroLBS · Traditional 11/13/1979SE
K790776Dade Low Ionic Strength Soluition (Liss)KSG · Traditional 05/23/1979SE
K790767Immu-Tek Automatic CentrifugeKSN · Traditional 05/23/1979SE
K790571Quik-StainIAF · Traditional 04/23/1979SE

Questions and answers

When was Blood Fluid Filters cleared by the FDA?

Blood Fluid Filters (K792723) received a 510(k) decision of Substantially Equivalent on January 21, 1980, 21 days after the submission was received.

What is the product code of K792723?

The FDA product code is JKA – Tubes, Vials, Systems, Serum Separators, Blood Collection, a Class II (moderate risk) device regulated under 21 CFR 862.1675.