EXTENDED RANGE HS CRP KIT, CAT NO:9200— 510(k) K030044
Substantially EquivalentReference Diagnostics, Inc.
FDA 510(k) clearance K030044 for EXTENDED RANGE HS CRP KIT, CAT NO:9200, Substantially Equivalent on 2003-09-30. Applicant: Reference Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Reference Diagnostics, 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
- Bedford, MA, US
Recent devices under product code DCK
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