ACCURUN 146 CMV IGM POSITIVE CONTROL— 510(k) K972884
Substantially EquivalentBoston Biomedica, Inc.
FDA 510(k) clearance K972884 for ACCURUN 146 CMV IGM POSITIVE CONTROL, Substantially Equivalent on 1997-08-22. Applicant: Boston Biomedica, Inc.. Device class: 2.
Clearance details
- Applicant
- Boston Biomedica, Inc.
- Product code
- Code LKQ
- Device class
- Class 2
- Regulation
- 21 CFR 866.3175
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Bridgewater, MA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.