Human C-5 Radial Immunodiffusion Kit

FDA 510(k) K950102 · Kent Laboratories, Inc.

Substantially Equivalent

510(k) numberK950102

Submission

Device name
Human C-5 Radial Immunodiffusion Kit
Applicant
Kent Laboratories, Inc.
Redmond, WA, US
Received
January 11, 1995
Decision date
April 10, 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
K942326Human C5 Rid KitsDAY · Traditional Jay H. Geller08/24/1995SE
K772075Radial Immunodiffusion Kit-ComplementDAY · Traditional Gelman Instrument Co.02/03/1978SE

More from Gelman Instrument Co.

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K951966Human Prealbumin Radial Immunodiffusion KitJZJ · Traditional 06/01/1995SE
K951968Human C1Q Radial Immunodiffusion KitDAK · Traditional 05/30/1995SE
K951967Human C1 Inactivator or C-1 Esterase Inhibitor Radial Immunodiffusion KitDBA · Traditional 05/30/1995SE
K85068372 Determ. Size Radial Immunodiffusion Test ALPHA2DEB · Traditional 11/27/1985SE
K85068272 Determ. Size Radial Immuno. Test Human CeruloplDDB · Traditional 11/25/1985SE
K850691Antiserum to Human Apolipoprotein A-IMSJ · Traditional 11/01/1985SE
K850690Antiserum to Human Apolipoprotein BMSJ · Traditional 11/01/1985SE
K850686Antiserum to Human PrealbuminJZJ · Traditional 11/01/1985SE
K831961Immunodiffusion Test Human AntithrombinJBQ · Traditional 08/11/1983SE
K831960Test for Human Alpha One Acid Glyco-LKL · Traditional 07/19/1983SE

Questions and answers

When was Human C-5 Radial Immunodiffusion Kit cleared by the FDA?

Human C-5 Radial Immunodiffusion Kit (K950102) received a 510(k) decision of Substantially Equivalent on April 10, 1995, 89 days after the submission was received.

What is the product code of K950102?

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