Lifecell Recovery Container

FDA 510(k) K893787 · Baxter Healthcare Corp

Substantially Equivalent

510(k) numberK893787

Submission

Device name
Lifecell Recovery Container
Applicant
Baxter Healthcare Corp
Round Lake, IL, US
Received
May 22, 1989
Decision date
June 23, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KJF – System, Suspension, Cell Culture
Device class
Class I (low risk)
Regulation
21 CFR 864.2240
Specialty
Hematology

Other 510(k)s with product code KJF

510(k)DeviceApplicantDecision
K892645Amicon Vitafiber Flo-Path Biorect/Vls Cell Cult SyKJF · Traditional Amicon, Inc.06/13/1989SE
K875221Tooth Preserving SystemKJF · Traditional Biological Rescue Products, Inc.04/14/1988SE
K780305CellKJF · Traditional Dynatech Laboratories, Inc.03/27/1978SE

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Questions and answers

When was Lifecell Recovery Container cleared by the FDA?

Lifecell Recovery Container (K893787) received a 510(k) decision of Substantially Equivalent on June 23, 1989, 32 days after the submission was received.

What is the product code of K893787?

The FDA product code is KJF – System, Suspension, Cell Culture, a Class I (low risk) device regulated under 21 CFR 864.2240.