GLUCOSE-HK TEST (GLUC-HK) ITEM #65665— 510(k) K884736
Substantially EquivalentEm Diagnostic Systems, Inc.
FDA 510(k) clearance K884736 for GLUCOSE-HK TEST (GLUC-HK) ITEM #65665, Substantially Equivalent on 1989-01-03. Applicant: Em Diagnostic Systems, Inc..
Clearance details
- Applicant
- Em Diagnostic Systems, Inc.
- Product code
- Code CFR
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gibbstown, NJ, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.