ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK ADVANTAGE H TEST STRIPS— 510(k) K973662
Substantially EquivalentBoehringer Mannheim Corp.
FDA 510(k) clearance K973662 for ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK ADVANTAGE H TEST STRIPS, Substantially Equivalent on 1997-12-15. Applicant: Boehringer Mannheim Corp..
Clearance details
- Applicant
- Boehringer Mannheim Corp.
- Product code
- Code LFR
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Adverse events under product code LFR
product code LFR- Death
- 3
- Malfunction
- 1,634
- Total
- 1,637
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.