Fiagen Ferritin

FDA 510(k) K882822 · Cyberfluor, Inc.

Substantially Equivalent

510(k) numberK882822

Submission

Device name
Fiagen Ferritin
Applicant
Cyberfluor, Inc.
Ontario M5t 1x4, CA
Received
July 8, 1988
Decision date
August 4, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DFL – Igm, Ferritin, Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5550
Specialty
Immunology

Other 510(k)s with product code DFL

510(k)DeviceApplicantDecision
K883493Technicon DPA-1 Immunoglobulin MDFL · Traditional Technicon Instruments Corp.09/22/1988SE
K772079Radial Immunodiffusion Kit-Immunoglob.MDFL · Traditional Gelman Instrument Co.02/03/1978SE

More from Gelman Instrument Co.

510(k)DeviceDecision
K923410Fiagen ProgesteroneJLS · Traditional 12/03/1992SE
K905656Flagen Triiodothyronine (T3) AssayCDP · Traditional 01/23/1991SE
K904539Flagen TM Free T4CEC · Traditional 11/30/1990SE
K900621Fiagen(Tm) Hlh.SCEP · Traditional 03/01/1990SE
K895186Fiagen T3 Uptake Catalogue #101-402KHQ · Traditional 11/08/1989SE
K895396Cyberfluor Fiagen TSHJLW · Traditional 10/31/1989SE
K884708Fiagen HFSH Time-Resolved Fluoroimmunoassay KitCGJ · Traditional 01/17/1989SE
K884707Fiagen Digoxin Time-Resolved Fluoroimmunoassay KitLCS · Traditional 01/17/1989SE
K884201Fiagen TBG Time-Resolved Fluoroimmunoassay KitCEE · Traditional 12/14/1988SE
K883182Fiagen Rubella IggLFX · Traditional 10/31/1988SE

Questions and answers

When was Fiagen Ferritin cleared by the FDA?

Fiagen Ferritin (K882822) received a 510(k) decision of Substantially Equivalent on August 4, 1988, 27 days after the submission was received.

What is the product code of K882822?

The FDA product code is DFL – Igm, Ferritin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5550.