Tissue Culture Bag

FDA 510(k) K870865 · American Fluoroseal Corp.

Substantially Equivalent

510(k) numberK870865

Submission

Device name
Tissue Culture Bag
Applicant
American Fluoroseal Corp.
Silver Spring, MD, US
Received
March 3, 1987
Decision date
March 30, 1987
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
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
K853441Fetal Bovine Serum in Transfer ContainerKJA · Traditional Newport Biosystems, Inc.08/26/1985SE

More from Newport Biosystems, Inc.

510(k)DeviceDecision
K933228Kapton Peel PouchKJA · Traditional 03/30/1994SE

Questions and answers

When was Tissue Culture Bag cleared by the FDA?

Tissue Culture Bag (K870865) received a 510(k) decision of Substantially Equivalent on March 30, 1987, 27 days after the submission was received.

What is the product code of K870865?

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