GILCHEM Y-GT REAGENT— 510(k) K822149
Substantially EquivalentGilford Diagnostics
FDA 510(k) clearance K822149 for GILCHEM Y-GT REAGENT, Substantially Equivalent on 1982-08-12. Applicant: Gilford Diagnostics. Device class: 1.
Clearance details
- Applicant
- Gilford Diagnostics
- Product code
- Code JPZ
- Device class
- Class 1
- Regulation
- 21 CFR 862.1360
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code JPZ
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