TINA-QUANT D-DIMER TEST SYSTEM— 510(k) K062203
Substantially EquivalentRoche Diagnostics Corp.
FDA 510(k) clearance K062203 for TINA-QUANT D-DIMER TEST SYSTEM, Substantially Equivalent on 2007-03-14. Applicant: Roche Diagnostics Corp.. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics Corp.
- Product code
- Code GHH
- Device class
- Class 2
- Regulation
- 21 CFR 864.7320
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code GHH
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- K070453 — OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL
- K042890 — TRIAGE D-DIMER TEST, MODEL 98100
- K030740 — MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM
More clearances from Roche Diagnostics Corp.
view allRecalls naming K062203
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 K062203.
Data sourced from openFDA. This site is unofficial and independent of the FDA.