ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) POSITIVE CONTROL— 510(k) K972307
Substantially EquivalentBoston Biomedica, Inc.
FDA 510(k) clearance K972307 for ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) POSITIVE CONTROL, Substantially Equivalent on 1997-08-07. Applicant: Boston Biomedica, Inc.. Device class: 1.
Clearance details
- Applicant
- Boston Biomedica, Inc.
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- 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.