Cell

FDA 510(k) K780305 · Dynatech Laboratories, Inc.

Substantially Equivalent

510(k) numberK780305

Submission

Device name
Cell
Applicant
Dynatech Laboratories, Inc.
Mchenry, IL, US
Received
February 23, 1978
Decision date
March 27, 1978
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
K893787Lifecell Recovery ContainerKJF · Traditional Baxter Healthcare Corp06/23/1989SE
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

More from Biological Rescue Products, Inc.

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K962265MLX Microtiter Plate LuminometerJSE · Traditional 07/25/1996SE
K934111MR7000 with Time Manager Software (TMS)JQP · Traditional 11/02/1994SE
K943701MRX Microplate ReaderJJQ · Traditional 10/20/1994SE
K923456Microlite Microtiter Plate Luminometer ML3000JJQ · Traditional 10/13/1992SE
K915896Microlite Microtiter Plate Luminometer ML2250/MODIJJQ · Traditional 05/04/1992SE
K920888Microlite Microtiter Plate Luminometer ML2200KHO · Traditional 03/19/1992SE
K913590Microlite ML 1000 Microtiter Plate LuminometerJJQ · Traditional 10/25/1991SE
K895313Microlite ML 1000 (Model 3) Microplate LuminometerJJQ · Traditional 10/17/1989SE
K894645Immulon 1,2,3,AND 4 Dividastrips TMJTC · Traditional 10/17/1989SE
K894687Dynatech MR 5000, Catalog #011-976-0600JJQ · Traditional 08/31/1989SE

Questions and answers

When was Cell cleared by the FDA?

Cell (K780305) received a 510(k) decision of Substantially Equivalent on March 27, 1978, 32 days after the submission was received.

What is the product code of K780305?

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