Human C5 Rid Kits

FDA 510(k) K942326 · Jay H. Geller

Substantially Equivalent

510(k) numberK942326

Submission

Device name
Human C5 Rid Kits
Applicant
Jay H. Geller
Santa Monica, CA, US
Received
May 13, 1994
Decision date
August 24, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
DAY – Complement C5, Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5240
Specialty
Immunology

Other 510(k)s with product code DAY

510(k)DeviceApplicantDecision
K950102Human C-5 Radial Immunodiffusion KitDAY · Traditional Kent Laboratories, Inc.04/10/1995SE
K772075Radial Immunodiffusion Kit-ComplementDAY · Traditional Gelman Instrument Co.02/03/1978SE

More from Gelman Instrument Co.

510(k)DeviceDecision
K971658Mouse Liver Kidney Stomach Diagnostic Test KitDBL · Traditional 05/23/1997SE
K950015Human Protein C Rid Test KitGGP · Traditional 03/06/1995SE
K943334Hawley Retainer Orthodontic Applicance KitDZC · Traditional 10/05/1994SE

Questions and answers

When was Human C5 Rid Kits cleared by the FDA?

Human C5 Rid Kits (K942326) received a 510(k) decision of Substantially Equivalent on August 24, 1995, 468 days after the submission was received.

What is the product code of K942326?

The FDA product code is DAY – Complement C5, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5240.