MODIFIED DDI SEROCARD HERPES IGG TEST KIT— 510(k) K884246
Substantially EquivalentDisease Detection International, Inc.
FDA 510(k) clearance K884246 for MODIFIED DDI SEROCARD HERPES IGG TEST KIT, Substantially Equivalent on 1989-04-10. Applicant: Disease Detection International, Inc.. Device class: 2.
Clearance details
- Applicant
- Disease Detection International, Inc.
- Product code
- Code LGC
- Device class
- Class 2
- Regulation
- 21 CFR 866.3305
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
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