D3 HEMATOLOGY ANALYZER, MODEL D3— 510(k) K071562
Substantially EquivalentDrew Scientific, Inc.
FDA 510(k) clearance K071562 for D3 HEMATOLOGY ANALYZER, MODEL D3, Substantially Equivalent on 2007-12-11. Applicant: Drew Scientific, Inc.. Device class: 2.
Clearance details
- Applicant
- Drew Scientific, Inc.
- Product code
- Code GKZ
- Device class
- Class 2
- Regulation
- 21 CFR 864.5220
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dallas, TX, US
Recent devices under product code GKZ
view allMore clearances from Drew Scientific, Inc.
view allAdverse events under product code GKZ
product code GKZ- Malfunction
- 1,205
- Total
- 1,205
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K071562
K-number listed on FDA's recall record- Z-2656-2017 — Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.
- Z-1576-2016 — Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reagent 5L, enzymatic cleaner 750 mL, and a lysing reagent 125 mL.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K071562.
Data sourced from openFDA. This site is unofficial and independent of the FDA.