EBNA-1 IGM ELISA TEST SYSTEM— 510(k) K980598
Substantially EquivalentClark Laboratories, Inc.
FDA 510(k) clearance K980598 for EBNA-1 IGM ELISA TEST SYSTEM, Substantially Equivalent on 1998-05-01. Applicant: Clark Laboratories, Inc.. Device class: 1.
Clearance details
- Applicant
- Clark Laboratories, 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
- Frederick, MD, US
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More clearances from Clark Laboratories, Inc.
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