BIOTEST ANTI-EBV RECOMBINANT, EA IGM— 510(k) K983842
Substantially EquivalentBiotest Diagnostics Corp.
FDA 510(k) clearance K983842 for BIOTEST ANTI-EBV RECOMBINANT, EA IGM, Substantially Equivalent on 1999-06-09. Applicant: Biotest Diagnostics Corp.. Device class: 1.
Clearance details
- Applicant
- Biotest Diagnostics Corp.
- Product code
- Code LSE
- Device class
- Class 1
- Regulation
- 21 CFR 866.3235
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Denville, NJ, US
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More clearances from Biotest Diagnostics Corp.
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