Antiserum to Human Igg

FDA 510(k) K790704 · Kent Laboratories, Inc.

Unknown

510(k) numberK790704

Submission

Device name
Antiserum to Human Igg
Applicant
Kent Laboratories, Inc.
Mchenry, IL, US
Received
April 12, 1979
Decision date
April 12, 1979
Decision
Unknown (SESP)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DEW – Igg, Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5510
Specialty
Immunology

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K962202Quantex IggDEW · Traditional Instrumentation Laboratory CO09/26/1996SE

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K950102Human C-5 Radial Immunodiffusion KitDAY · Traditional 04/10/1995SE
K85068372 Determ. Size Radial Immunodiffusion Test ALPHA2DEB · Traditional 11/27/1985SE
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K850691Antiserum to Human Apolipoprotein A-IMSJ · Traditional 11/01/1985SE
K850690Antiserum to Human Apolipoprotein BMSJ · Traditional 11/01/1985SE
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Questions and answers

When was Antiserum to Human Igg cleared by the FDA?

Antiserum to Human Igg (K790704) received a 510(k) decision of Unknown on April 12, 1979, 0 days after the submission was received.

What is the product code of K790704?

The FDA product code is DEW – Igg, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.