TINA-QUANT ALBUMIN GEN 2— 510(k) K101203
Substantially EquivalentRoche Diagnostics
FDA 510(k) clearance K101203 for TINA-QUANT ALBUMIN GEN 2, Substantially Equivalent on 2010-09-10. Applicant: Roche Diagnostics. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics
- Product code
- Code DCF
- Device class
- Class 2
- Regulation
- 21 CFR 866.5040
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code DCF
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view allRecalls naming K101203
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K101203.
Data sourced from openFDA. This site is unofficial and independent of the FDA.