CLINISTAT TOTAL BILIRUBIN REAGENT TEST— 510(k) K892801
Substantially EquivalentHeraeus Kulzer, Inc.
FDA 510(k) clearance K892801 for CLINISTAT TOTAL BILIRUBIN REAGENT TEST, Substantially Equivalent on 1989-08-15. Applicant: Heraeus Kulzer, Inc.. Device class: 2.
Clearance details
- Applicant
- Heraeus Kulzer, Inc.
- Product code
- Code CIG
- Device class
- Class 2
- Regulation
- 21 CFR 862.1110
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Elkhart, IN, US
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