Modified CRP Latex Test
FDA 510(k) K880016 · Sclavo, Inc.
510(k) numberK880016
Submission
- Device name
- Modified CRP Latex Test
- Applicant
- Sclavo, Inc.
Wayne, NJ, US - Received
- January 5, 1988
- Decision date
- February 25, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K141689 | FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive…DCK · Traditional | Qualigen, Inc. | 01/07/2015SE |
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Questions and answers
When was Modified CRP Latex Test cleared by the FDA?
Modified CRP Latex Test (K880016) received a 510(k) decision of Substantially Equivalent on February 25, 1988, 51 days after the submission was received.
What is the product code of K880016?
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.