C-Reactive Protein (Crp):A Latex Slide Test
FDA 510(k) K962019 · Teco Diagnostics
510(k) numberK962019
Submission
- Device name
- C-Reactive Protein (Crp):A Latex Slide Test
- Applicant
- Teco Diagnostics
Placentia, CA, US - Received
- May 23, 1996
- Decision date
- November 25, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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Questions and answers
When was C-Reactive Protein (Crp):A Latex Slide Test cleared by the FDA?
C-Reactive Protein (Crp):A Latex Slide Test (K962019) received a 510(k) decision of Substantially Equivalent on November 25, 1996, 186 days after the submission was received.
What is the product code of K962019?
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.