ACS THERAPEUTIC DRUG MONIT CONTR, SET II LEVEL III— 510(k) K911171
Substantially EquivalentAnalytical Control Systems, Inc.
FDA 510(k) clearance K911171 for ACS THERAPEUTIC DRUG MONIT CONTR, SET II LEVEL III, Substantially Equivalent on 1991-05-01. Applicant: Analytical Control Systems, Inc.. Device class: 1.
Clearance details
- Applicant
- Analytical Control Systems, Inc.
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fishers, IN, US
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