ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL III— 510(k) K911178
Substantially EquivalentAnalytical Control Systems, Inc.
FDA 510(k) clearance K911178 for ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL III, Substantially Equivalent on 1991-05-01. Applicant: Analytical Control Systems, Inc..
Clearance details
- Applicant
- Analytical Control Systems, Inc.
- Product code
- Code JJX
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fishers, IN, US
Adverse events under product code JJX
product code JJX- Other
- 2
- Total
- 2
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.