In Vitro 2.5X Roller Bottle

FDA 510(k) K873137 · In Vitro Scientific Products

Substantially Equivalent

510(k) numberK873137

Submission

Device name
In Vitro 2.5X Roller Bottle
Applicant
In Vitro Scientific Products
Oak View, CA, US
Received
August 10, 1987
Decision date
August 24, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

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

Other 510(k)s with product code KJC

510(k)DeviceApplicantDecision
K880509Multisurface Roller Bottle (M.S.R.B.)KJC · Traditional Motil Plastics , Ltd.04/01/1988SE
K791049Synalon Roller BottleKJC · Traditional Dynatech Laboratories, Inc.06/28/1979SE

Questions and answers

When was In Vitro 2.5X Roller Bottle cleared by the FDA?

In Vitro 2.5X Roller Bottle (K873137) received a 510(k) decision of Substantially Equivalent on August 24, 1987, 14 days after the submission was received.

What is the product code of K873137?

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