DIRECT ELISA FOR HERPES SIMPLEX VIRUS— 510(k) K853307
Substantially EquivalentFairleigh Dickinson Laboratories, Inc.
FDA 510(k) clearance K853307 for DIRECT ELISA FOR HERPES SIMPLEX VIRUS, Substantially Equivalent on 1985-12-23. Applicant: Fairleigh Dickinson Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Fairleigh Dickinson Laboratories, Inc.
- Product code
- Code GQN
- Device class
- Class 2
- Regulation
- 21 CFR 866.3305
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Abilene, TX, US
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