CRP Slide Test Kit
FDA 510(k) K840699 · Difco Laboratories, Inc.
510(k) numberK840699
Submission
- Device name
- CRP Slide Test Kit
- Applicant
- Difco Laboratories, Inc.
Mchenry, IL, US - Received
- February 16, 1984
- Decision date
- March 23, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DCN – System, Test, C-Reactive Protein
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5270
- Specialty
- Immunology
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Questions and answers
When was CRP Slide Test Kit cleared by the FDA?
CRP Slide Test Kit (K840699) received a 510(k) decision of Substantially Equivalent on March 23, 1984, 36 days after the submission was received.
What is the product code of K840699?
The FDA product code is DCN – System, Test, C-Reactive Protein, a Class II (moderate risk) device regulated under 21 CFR 866.5270.