KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON— 510(k) K911801
Substantially EquivalentGds Technology, LLC
FDA 510(k) clearance K911801 for KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON, Substantially Equivalent on 1991-07-01. Applicant: Gds Technology, LLC. Device class: 1.
Clearance details
- Applicant
- Gds Technology, LLC
- Product code
- Code JIN
- Device class
- Class 1
- Regulation
- 21 CFR 862.1435
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Elkhart, IN, US
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