MI DAS 1000 AUTOMATIC SLIDE STAINER— 510(k) K821830
Substantially EquivalentInnovative Medical Systems, Inc.
FDA 510(k) clearance K821830 for MI DAS 1000 AUTOMATIC SLIDE STAINER, Substantially Equivalent on 1982-07-22. Applicant: Innovative Medical Systems, Inc..
Clearance details
- Applicant
- Innovative Medical Systems, Inc.
- Product code
- Code KPA
- Advisory panel
- Pathology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Adverse events under product code KPA
product code KPA- Malfunction
- 1,177
- Total
- 1,177
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.