Tissue Culture Tubes

FDA 510(k) K873889 · Nunc, Inc.

Substantially Equivalent

510(k) numberK873889

Submission

Device name
Tissue Culture Tubes
Applicant
Nunc, Inc.
Riverside, CA, US
Received
September 23, 1987
Decision date
November 25, 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
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
K853441Fetal Bovine Serum in Transfer ContainerKJA · Traditional Newport Biosystems, Inc.08/26/1985SE

More from Newport Biosystems, Inc.

510(k)DeviceDecision
K873891Tissue Culture DishesKIZ · Traditional 11/25/1987SE
K873890Tissue Culture FlasksKJA · Traditional 11/25/1987SE

Questions and answers

When was Tissue Culture Tubes cleared by the FDA?

Tissue Culture Tubes (K873889) received a 510(k) decision of Substantially Equivalent on November 25, 1987, 63 days after the submission was received.

What is the product code of K873889?

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