510(k) K982079 ยท LFR Glucose Dehydrogenase, Glucose
ACCU-CHECK VOICEMATE
| Applicant | Boehringer Mannheim Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Aug 28, 1998 |
| Received | Jun 15, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982079
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 11, 2009 | Roche Diagnostics Corp. Roche ACCU-Chek Voicemate Meter, Roche Diagnostics, Indianapolis, IN; REF 12030802001 includes the Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Diagnostics, Indianapolis, IN. Model 3 Terminated |
LFR | None listed |
| Aug 5, 2006 | Roche Diagnostics Corp. ACCU-CHEK Voicemate System, Advantage Blood Glucose Meter and Voice Unit - English language version for the blind or visually impaired, Cat. no 2030802. Ref. no. 12030802001 with meter model no. 768. Terminated |
LFR | None listed |
| Aug 5, 2006 | Roche Diagnostics Corp. ACCU-CHEK Voicemate System, Advantage Blood Glucose Meter and Voice Unit - Spanish language version for the blind or visually impaired, Cat. no. 3040208. Ref. no. 03040208001 with meter model no. 768 Terminated |
LFR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.