Pulse CRP Test

FDA 510(k) K923768 · Pulse Scientific, Inc.

Substantially Equivalent

510(k) numberK923768

Submission

Device name
Pulse CRP Test
Applicant
Pulse Scientific, Inc.
Burlington, Ont., Canada, CA
Received
July 28, 1992
Decision date
December 1, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
DCK – C-Reactive Protein, Antigen, Antiserum, And Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5270
Specialty
Immunology

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More from Diazyme Laboratories

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Questions and answers

When was Pulse CRP Test cleared by the FDA?

Pulse CRP Test (K923768) received a 510(k) decision of Substantially Equivalent on December 1, 1992, 126 days after the submission was received.

What is the product code of K923768?

The FDA product code is DCK – C-Reactive Protein, Antigen, Antiserum, And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5270.