Immustrip Hama Igg

FDA 510(k) K972873 · Immunomedics, Inc.

Substantially Equivalent

510(k) numberK972873

Submission

Device name
Immustrip Hama Igg
Applicant
Immunomedics, Inc.
Morris Plains, NJ, US
Received
August 4, 1997
Decision date
March 17, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DAK – Complement C1q, Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5240
Specialty
Immunology

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K873741Immustrip(Tm) SM Elisa Test SystemLKP · Traditional 11/04/1987SE
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Questions and answers

When was Immustrip Hama Igg cleared by the FDA?

Immustrip Hama Igg (K972873) received a 510(k) decision of Substantially Equivalent on March 17, 1998, 225 days after the submission was received.

What is the product code of K972873?

The FDA product code is DAK – Complement C1q, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5240.