CLINITEK ATLAS AUTOMATED URINE CHEMISTRY ANALYZER— 510(k) K946183
Substantially EquivalentHeraeus Kulzer, Inc.
FDA 510(k) clearance K946183 for CLINITEK ATLAS AUTOMATED URINE CHEMISTRY ANALYZER, Substantially Equivalent on 1995-02-22. Applicant: Heraeus Kulzer, Inc.. Device class: 1.
Clearance details
- Applicant
- Heraeus Kulzer, Inc.
- Product code
- Code KQO
- Device class
- Class 1
- Regulation
- 21 CFR 862.2900
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mishawaka, IN, US
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