STAT/PB REAGENT— 510(k) K843839
Substantially EquivalentTri-Tech, Inc.
FDA 510(k) clearance K843839 for STAT/PB REAGENT, Substantially Equivalent on 1985-01-03. Applicant: Tri-Tech, Inc.. Device class: 2.
Clearance details
- Applicant
- Tri-Tech, Inc.
- Product code
- Code DOF
- Device class
- Class 2
- Regulation
- 21 CFR 862.3550
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Durham, NC, US
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