C-REACTIVE PROTEIN (CRP) AGGLUTINATION LATEX KIT— 510(k) K962049
Substantially EquivalentPolymedco, Inc.
FDA 510(k) clearance K962049 for C-REACTIVE PROTEIN (CRP) AGGLUTINATION LATEX KIT, Substantially Equivalent on 1996-12-18. Applicant: Polymedco, Inc.. Device class: 2.
Clearance details
- Applicant
- Polymedco, Inc.
- Product code
- Code DCK
- Device class
- Class 2
- Regulation
- 21 CFR 866.5270
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cortlandt Manor, NY, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.