Fetal Bovine Serum in Transfer Container

FDA 510(k) K853441 · Newport Biosystems, Inc.

Substantially Equivalent

510(k) numberK853441

Submission

Device name
Fetal Bovine Serum in Transfer Container
Applicant
Newport Biosystems, Inc.
Santa Ana, CA, US
Received
August 13, 1985
Decision date
August 26, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KJA – Flask, Tissue Culture
Device class
Class I (low risk)
Regulation
21 CFR 864.2240
Specialty
Hematology

Other 510(k)s with product code KJA

510(k)DeviceApplicantDecision
K972404Vacutainer Brand Safety Blood Collection Assembly(Multiple)KJA · Traditional Bd Becton Dickinson Vacutainer Systems Preanalytic07/22/1997SE
K933228Kapton Peel PouchKJA · Traditional American Fluoroseal Corp.03/30/1994SE
K885121Cell ScraperKJA · Traditional Bd Becton Dickinson Vacutainer Systems Preanalytic12/28/1988SE
K873890Tissue Culture FlasksKJA · Traditional Nunc, Inc.11/25/1987SE
K873889Tissue Culture TubesKJA · Traditional Nunc, Inc.11/25/1987SE
K871324Du Pont Stericell Cell Culture SystemKJA · Traditional E.I. Dupont DE Nemours & Co., Inc.04/14/1987SE
K870865Tissue Culture BagKJA · Traditional American Fluoroseal Corp.03/30/1987SE
K864021Tissue Culture FlaskKJA · Traditional Fenwal Laboratories10/29/1986SE
K862152Tissue Culture Flask PL 732 Plastic Accessory ProdKJA · Traditional Travenol Laboratories, S.A.06/16/1986SE
K861253Tissue Culture Flask PL 732 PlasticKJA · Traditional Travenol Laboratories, S.A.04/11/1986SE

More from Travenol Laboratories, S.A.

510(k)DeviceDecision
K881648Transfer Container HumidifierCAF · Traditional 12/30/1988SE
K860282Rpmi 1640 W/Glutamine W/HepesKIT · Traditional 02/05/1986SE
K855085Tissue Culture MediaKIT · Traditional 01/13/1986SE

Questions and answers

When was Fetal Bovine Serum in Transfer Container cleared by the FDA?

Fetal Bovine Serum in Transfer Container (K853441) received a 510(k) decision of Substantially Equivalent on August 26, 1985, 13 days after the submission was received.

What is the product code of K853441?

The FDA product code is KJA – Flask, Tissue Culture, a Class I (low risk) device regulated under 21 CFR 864.2240.