EBNA-CHECK(TM) TEST KIT— 510(k) K891542
Substantially EquivalentDiagnostic Technology, Inc.
FDA 510(k) clearance K891542 for EBNA-CHECK(TM) TEST KIT, Substantially Equivalent on 1989-06-20. Applicant: Diagnostic Technology, Inc.. Device class: 1.
Clearance details
- Applicant
- Diagnostic Technology, Inc.
- Product code
- Code LLM
- Device class
- Class 1
- Regulation
- 21 CFR 866.3235
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hauppauge, NY, US
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