TINA-QUANT ALPHA-1 ANTITRYPSIN— 510(k) K010978
Substantially EquivalentRochdiag
FDA 510(k) clearance K010978 for TINA-QUANT ALPHA-1 ANTITRYPSIN, Substantially Equivalent on 2001-05-18. Applicant: Rochdiag. Device class: 2.
Clearance details
- Applicant
- Rochdiag
- Product code
- Code DEM
- Device class
- Class 2
- Regulation
- 21 CFR 866.5130
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code DEM
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- K052819 — VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III
- K050596 — QUANTIA A1-AT
More clearances from Rochdiag
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