POCKIT HSV 2 RAPID TEST— 510(k) K983886
Substantially EquivalentDiagnology , Ltd.
FDA 510(k) clearance K983886 for POCKIT HSV 2 RAPID TEST, Substantially Equivalent on 1999-08-19. Applicant: Diagnology , Ltd.. Device class: 2.
Clearance details
- Applicant
- Diagnology , Ltd.
- 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
- West Cadwell, NJ, US
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Recalls naming K983886
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K983886.
Data sourced from openFDA. This site is unofficial and independent of the FDA.