510(k) K071562 ยท GKZ Counter, Differential Cell
D3 HEMATOLOGY ANALYZER, MODEL D3
| Applicant | Drew Scientific, Inc., Dallas TX, US |
| Decision | Substantially Equivalent, Dec 11, 2007 |
| Received | Jun 7, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071562
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 21, 2017 | JAS Diagnostics Inc. Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent. Terminated |
GKZ | None listed |
| Mar 10, 2016 | Jas Diagnostics/Drew Scientific Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reagent 5L, enzymatic cleaner 750 mL, and a lysing reagent 125 mL. Terminated |
GKZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.