Kallestad QM300 C-Reactive Protein Antibody Pack
FDA 510(k) K880728 · Kallestad Diag, A Div. of Erbamont, Inc.
510(k) numberK880728
Submission
- Device name
- Kallestad QM300 C-Reactive Protein Antibody Pack
- Applicant
- Kallestad Diag, A Div. of Erbamont, Inc.
Chaska, MN, US - Received
- February 23, 1988
- Decision date
- March 25, 1988
- 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 Kallestad QM300 C-Reactive Protein Antibody Pack cleared by the FDA?
Kallestad QM300 C-Reactive Protein Antibody Pack (K880728) received a 510(k) decision of Substantially Equivalent on March 25, 1988, 31 days after the submission was received.
What is the product code of K880728?
The FDA product code is DCN – System, Test, C-Reactive Protein, a Class II (moderate risk) device regulated under 21 CFR 866.5270.